Indication

CDER Division

Acarbose

Type 2 Diabetes.

Metabolic And Endocrine Drug Products

Acebutolol

Hypertension.

Cardio-Renal Drug Products

Acetaminophen/ Aspirin/ Caffeine

Treatment of pain associated with migraine headache.

Over-The-Counter Drug Products

Adenosine

Conversion to sinus rhythm of paroxysmal supraventricular tachycardia, including that associated with accessory bypass tracts.

Cardio-Renal Drug Products

Albendazole

Treatment of hydatid disease and neurocysticercosis.

Special Pathogen And Immunologic Drug Products

Albuterol (racemic and (R) enantiomer)

Treatment and prevention of bronchospasm in patients with reversible obstructive airway disease.

Pulmonary Drug Products

Alfentanil

Anesthesia maintenance, induction of anesthesia, monitored anesthesia care.

Anesthetic, Critical Care And Addiction Drug Products

Alprazolam

Anxiety.

Neuropharmacological Drug Products

Amantadine

Prophylaxis and treatment of illness caused by influenza virus.

Anti-Viral Drug Products

Amifostine

Chemoprotective agent that selectively protects against the serious toxicities associated with intensive regimens of platinum and alkylating agent chemotherapy.

Oncology Drug Products

Amiloride

Hypertension.

Cardio-Renal Drug Products

Aminocaproic Acid

Enhancing hemostasis when fibrinolysis contributes to bleeding.

Gastrointestinal And Coagulation Drug Products

Amiodarone

Treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically destabilizing ventricular tachycardia.

Cardio-Renal Drug Products

Amlexanox

Treatment of oral aphthous ulcers.

Dermatologic And Dental Drug Products

Amlodipine

Hypertension.

Cardio-Renal Drug Products

Amphetamine/ Dextroamphetamine

ADHD.

Neuropharmacological Drug Products

Amphotericin B

Treat potentially life-threatening fungal infections.

Special Pathogen And Immunologic Drug Products

Ampicillin

Respiratory tract infections, bacterial meningitis, septicemia, endocarditis, UTI, and gastrointestinal infections.

Anti-Infective Drug Products

Ampicillin/sulbactam

Skin/skin structure infections and intraabdominal infections.

Anti-Infective Drug Products

Apraclonidine

Adjunctive therapy in glaucoma patients. Control of acute IOP elevation after anterior-segment laser surgery.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Argatroban

Anticoagulation in patients with heparin-induced thrombocytopenia.

Gastrointestinal And Coagulation Drug Products

Atorvastatin

Heterozygous familial hypercholesterolemia.

Metabolic And Endocrine Drug Products

Atovaquone

Treatment and prophylaxis of PCP infection in patients with HIV.

Special Pathogen And Immunologic Drug Products

Atracurium

Neuromuscular blocking agent.

Anesthetic, Critical Care And Addiction Drug Products

Atropine

Reversal agent or antagonist of nondepolarizing muscle relaxants.

Anesthetic, Critical Care And Addiction Drug Products

Azathioprine

Juvenile rheumatoid arthritis.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Azelastine

Allergic rhinitis.

Pulmonary Drug Products

Azithromycin

Prevention of MAI infection.

Special Pathogen And Immunologic Drug Products

Azithromycin

Pneumonia (community acquired).

Anti-Infective Drug Products

Aztreonam

UTI, lower respiratory tract infections, septicemia, skin infections, intra-abdominal infections.

Anti-Infective Drug Products

Baclofen

Treatment of spasticity resulting from spinal cord injury or multiple sclerosis in patients whose oral baclofen therapy has failed.

Neuropharmacological Drug Products

Balsalazide

Treatment of mild to moderate ulcerative colitis.

Gastrointestinal And Coagulation Drug Products

Beclomethasone

For patients who require chronic treatment with corticosteroids for control of the symptoms of bronchial asthma. Relief of symptoms of allergic and non-allergic (vasomotor) rhinitis.

Pulmonary Drug Products

Benazepril

Hypertension.

Cardio-Renal Drug Products

Bendroflumethiazide

Hypertension.

Cardio-Renal Drug Products

Betamethasone

Corticosteroid responsive dermatoses.

Dermatologic And Dental Drug Products

Betaxolol

Hypertension.

Cardio-Renal Drug Products

Betaxolol

Control of IOP for glaucoma and ocular hypertensive patients.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Betaxolol/ Pilocarpine

Lowering of intraocular pressure in patients with primary open angle glaucoma or ocular hypertension.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Bitolterol

Prophylaxis and treatment of asthma or bronchospasm.

Pulmonary Drug Products

Brimonidine

Lowering intraocular pressure in patients with chronic open angle glaucoma or ocular hypertension.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Brinzolamide

Lower intraocular pressure.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Brompheniramine/ Pseudoephedrine

Cold and allergy relief.

Over-The-Counter Drug Products

Budesonide

Prevention and relief of symptoms of seasonal or perennial allergic and nonallergic (vasomotor) rhinitis. Treatment of bronchial asthma.

Pulmonary Drug Products

Bumetanide

Treatment of edema (CHF, liver or kidney disease).

Cardio-Renal Drug Products

Bupivacaine

Caudal/epidural anesthesia single administration or continuous infusions. Local anesthetic infiltration. Spinal/subarachnoid anesthesia. Intra-articular route. Regional nerve block. Subarachnoid use in neonates.

Anesthetic, Critical Care And Addiction Drug Products

Bupropion

Aid to smoking cessation treatment.

Anesthetic, Critical Care And Addiction Drug Products

Bupropion

Treatment of depression.

Neuropharmacological Drug Products

Buspirone

Anxiety.

Neuropharmacological Drug Products

Busulfan

Chronic myelogenous leukemia.

Oncology Drug Products

Calcipotriene

Treatment of plaque psoriasis.

Dermatologic And Dental Drug Products

Calcitriol

Management of hypocalcemia in patients undergoing chronic renal dialysis, end stage renal disease.

Metabolic And Endocrine Drug Products

Calcium acetate

For treatment of hyperphosphatemia in end stage renal failure patients.

Metabolic And Endocrine Drug Products

Candesartan

Hypertension.

Cardio-Renal Drug Products

Captopril

Treatment of heart failure. Hypertension.

Cardio-Renal Drug Products

Carmustine

Central nervous system malignancies, lymphoma.

Oncology Drug Products

Carteolol

Hypertension.

Cardio-Renal Drug Products

Carteolol

Treatment of chronic open-angle glaucoma or ocular hypertension.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Carvedilol

Treatment of heart failure.

Cardio-Renal Drug Products

Caspofungin

Treatment of invasive aspergillosis in patients refractory to or intolerant of other therapies.

Special Pathogen And Immunologic Drug Products

Cefdinir

Uncompliated skin and skin structure infections. Community-acquired pneumonia. Acute bacterial otitis media.

Anti-Infective Drug Products

Cefepime

Intra-abdominal infections. UTI, skin infections, pneumonia.

Anti-Infective Drug Products

Cefixime

Uncomplicated gonorrhea.

Anti-Infective Drug Products

Cefprozil

Otitis media. Uncomplicated skin and skin structure infections.

Anti-Infective Drug Products

Ceftizoxime

Lower respiratory tract infections, urinary tract infections, intra-abdominal infections, skin and skin structure infections, and bone and joint infections.

Anti-Infective Drug Products

Celecoxib

Rheumatoid arthritis.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Cephalexin

Bone and joint infections. Skin and skin structure infections.

Anti-Infective Drug Products

Cerivastatin

Heterozygous familial hypercholesterolemia.

Metabolic And Endocrine Drug Products

Cetirizine

Seasonal allergic rhinitis; perennial allergic rhinitis; and chronic idiopathic urticaria.

Pulmonary Drug Products

Chloroquine

Suppressive treatment and acute attacks of malaria due to P. vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum. Treatment of extra-intestinal amebiasis.

Special Pathogen And Immunologic Drug Products

Chlorothiazide

Hypertension.

Cardio-Renal Drug Products

Chlorpheniramine

Allergy and cold relief.

Over-The-Counter Drug Products

Chlorthalidone

Hypertension.

Cardio-Renal Drug Products

Cholestyramine

For relief of pruritus associated with partial biliary obstruction.

Gastrointestinal And Coagulation Drug Products

Cimetidine

Prevention of upper GI bleeding in critically ill patients. Treatment of symptomatic GERD. Treatment of erosive esophagitis. Treatment of ulcer disease.

Gastrointestinal And Coagulation Drug Products

Ciprofloxacin

Corneal ulcers and conjunctivitis.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Ciprofloxacin

Complicated intra-abdominal infections. Typhoid fever. Febrile neutropenia. Nosocomial pneumonia. Bone and joint infections. Infectious diarrhea.

Special Pathogen And Immunologic Drug Products

Cisatracurium

Intermediate duration neuromuscular blocking agent for use in the operating room and intensive care unit.

Anesthetic, Critical Care And Addiction Drug Products

Citalopram

Treatment of Depression.

Neuropharmacological Drug Products

Clarithromycin

Treatment of MAI infection.

Special Pathogen And Immunologic Drug Products

Clemastine

Allergic rhinitis and urticaria. Common cold.

Pulmonary Drug Products

Clemastine/ Phenylpropanolamine

Cold and allergy relief; relief of nasal congestion associated with sinusitis.

Over-The-Counter Drug Products

Clobetasol

Topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses.

Dermatologic And Dental Drug Products

Clomipramine

Obsessive compulsive disorders.

Neuropharmacological Drug Products

Clonazepam

Lennox-Gastaut syndrome, akinetic & myoclonic seizures; Pananti convulsion; treatment of (convulsions) akinetic myoclonic and absence seizure.

Neuropharmacological Drug Products

Clonidine

For continuous epidural administration as adjunctive therapy with intraspinal opiates for the treatment of pain in cancer patients.

Anesthetic, Critical Care And Addiction Drug Products

Clonidine

Hypertension.

Cardio-Renal Drug Products

Clopidogril

Prevent thrombotic events.

Cardio-Renal Drug Products

Clotrimazole/ Betamethasone

Treatment of tinea pedis, tinea cruris, and tinea corporis.

Dermatologic And Dental Drug Products

Clozapine

Psychotic disorders.

Neuropharmacological Drug Products

Corticorelin Ovine

Diagnostic aid for adrenal cortical function and Cushings syndrome.

Metabolic And Endocrine Drug Products

Cromolyn

Prophylaxis/treatment of asthma.

Pulmonary Drug Products

Cyclosporine

Juvenile rheumatoid arthritis.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

D-penicillamine

Juvenile rheumatoid arthritis.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Dacarbazine

Hodgkin's Disease.

Oncology Drug Products

Dapiprazole

Use in the practice of ophthalmology to reverse mydriasis.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Deferoxamine

Treatment of acute iron intoxication.

Gastrointestinal And Coagulation Drug Products

Delavirdine

Treatment of HIV infection.

Anti-Viral Drug Products

Desmopressin

Central diabetes insipidus. Treatment of hemophilia A and mild to moderate von Willebrand disease.

Metabolic And Endocrine Drug Products

Dexmedetomidine

Sedation of initially intubated and mechanically ventilated patients in an ICU setting.

Anesthetic, Critical Care And Addiction Drug Products

Dexrazoxane

For the prevention of cardiomyopathy associated with doxorubicin administration.

Oncology Drug Products

Dezocine

Pain management when use of opioid analgesic indicated.

Anesthetic, Critical Care And Addiction Drug Products

Diazepam

Management of selected, refractory patients with epilepsy, on stable regimes of AEDs, who require intermittent use of diazepam to control bouts of increased seizure activity. Anxiety disorders.

Neuropharmacological Drug Products

Diazoxide

Use in hypertensive emergencies.

Cardio-Renal Drug Products

Diclofenac

Treatment of postoperative inflammation following cataract extraction. Juvenile rheumatoid arthritis.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Diclofenac/Misoprostol

Treatment of rheumatoid arthritis in patients at high risk of developing NSAID-induced ulcers and their complications.

Gastrointestinal And Coagulation Drug Products

Didanosine

Treatment of HIV infection.

Anti-Viral Drug Products

Digoxin

CHF in specific cardiovascular disorders and malformations. For rapid control of ventricular rate in the face of supraventricular tachycardia.

Cardio-Renal Drug Products

Dihydroergotamine

Symptomatic treatment of common or classic migraine headaches.

Neuropharmacological Drug Products

Diltiazem

Hypertension.

Cardio-Renal Drug Products

Dimercaprol

Treatment of arsenic, gold, and mercury poisoning.

Gastrointestinal And Coagulation Drug Products

Disopyramide

Arrhythmias.

Cardio-Renal Drug Products

Divalproex

Therapy in simple (petit mal) & complex absence seizures & multiple seizure types. Monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Migraine prevention. Mania.

Neuropharmacological Drug Products

Dobutamine

Treatment of heart failure.

Cardio-Renal Drug Products

Dofetilide

Delay in recurrence of atrial fibrillation or flutter.

Cardio-Renal Drug Products

Dolasetron

Prevention of chemotherapy-induced emesis. Treatment of post-operative nausea and vomiting. Prevention of post-operative nausea and vomiting.

Gastrointestinal And Coagulation Drug Products

Dopamine

Treatment of heart failure.

Cardio-Renal Drug Products

Dorzolamide

Lower intraocular pressure.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Dorzolamide/Timolol

Lower intraocular pressue.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Doxacurium

Indicated as an adjunct to general anesthesia, to provide skeletal muscle relaxation during surgery.

Anesthetic, Critical Care And Addiction Drug Products

Doxazosin

Hypertension.

Cardio-Renal Drug Products

Doxepin

Treatment of cutaneous histamine-mediated pruritus accompanying eczematous dermatitis.

Dermatologic And Dental Drug Products

Doxercalciferol

Reduce IPTH levels in the management of secondary hyperparathyroidism in patients undergoing chronic renal dialysis.

Metabolic And Endocrine Drug Products

Droperidol

Antiemetic. Adjunct for sedation prior to or during a procedure. Adjunct to general anesthesia.

Anesthetic, Critical Care And Addiction Drug Products

Edrophonium

Reversal agent or antagonist of nondepolarizing neuromuscular blocking agents.

Anesthetic, Critical Care And Addiction Drug Products

Efavirenz

Treatment of HIV infection.

Anti-Viral Drug Products

Enalaprilat

Use in hypertensive emergencies.

Cardio-Renal Drug Products

Enoxacin

Complicated urinary tract infections.

Special Pathogen And Immunologic Drug Products

Enoxaparin

Treatment of deep venous thrombosis.

Gastrointestinal And Coagulation Drug Products

Epinephrine

Intraosseous and endotracheal for resuscitation.

Anesthetic, Critical Care And Addiction Drug Products

Epoprostenol

Pulmonary hypertension associated with scleroderma. Long term treatment of primary pulmonary hypertension.

Gastrointestinal And Coagulation Drug Products

Eprosartan

Hypertension.

Cardio-Renal Drug Products

Esomeprazole

Treatment of symptomatic GERD. Treatment of erosive esophagitis.

Gastrointestinal And Coagulation Drug Products

Ethacrynic acid

Hypertension.

Cardio-Renal Drug Products

Ethambutol

Pulmonary tuberculosis.

Special Pathogen And Immunologic Drug Products

Ethionamide

Active tuberculosis (after failing primary drugs).

Special Pathogen And Immunologic Drug Products

Ethosuximide

Control of absence epilepsy (petit mal).

Neuropharmacological Drug Products

Etomidate

As an adjunct to endotracheal intubation. For induction of anesthesia. As a premedicant/sedative prior to or during a procedure.

Anesthetic, Critical Care And Addiction Drug Products

Famciclovir

Herpes zoster and recurrent genital herpes. Treatment/suppression of recurrent genital herpes. Treatment of recurrent microcutaneous herpes simplex infection in HIV infected patients.

Anti-Viral Drug Products

Famotidine

Treatment of symptomatic GERD. Treatment of erosive esophagitis.

Gastrointestinal And Coagulation Drug Products

Felbamate

Monotherapy or adjunctive therapy for the treatment of partial seizures with and without generalization in patients with epilepsy.

Neuropharmacological Drug Products

Felodipine

Hypertension.

Cardio-Renal Drug Products

Fenoldopam

For emergency use in hypertensive emergencies.

Cardio-Renal Drug Products

Fentanyl

Transdermal for pain control. For epidural administration by single shot or continuous infusion for postoperative or general pain management. For continuous intravenous infusion in the critical care setting. For general anesthesia. As a premedicant prior to or during a procedure. By continuous infusion/patient controlled analgesia.

Anesthetic, Critical Care And Addiction Drug Products

Ferric Ammonium Citrate

Delineate the gastrointestinal tract in magnetic resonance imaging of the upper abdomen.

Medical Imaging And Radiopharmaceutical Drug Products

Ferrlecit

Iron deficiency anemia in chronic hemodialysis patients on erythropoetin.

Gastrointestinal And Coagulation Drug Products

Ferumoxides

Intended for the detection of lesions of the liver and spleen manifested by an alteration in RES distribution as an adjunct to MRI.

Medical Imaging And Radiopharmaceutical Drug Products

Ferumoxsil

Used with magnetic resonance imaging to enhance delineation of the bowel in order to distinguish it from adjacent organs and areas of suspected pathology.

Medical Imaging And Radiopharmaceutical Drug Products

Fexofenadine

Treatment of seasonal allergic rhinitis.

Pulmonary Drug Products

Fexofenadine/ Pseudoephedrine

Treatment of seasonal allergic rhinitis.

Pulmonary Drug Products

Flecainide

Treatment of life threatening ventricular arrhythmias. Prolonging the time to recurrence of supraventricular tachycardia.

Cardio-Renal Drug Products

Fluconazole

Treatment of cryptococcal meningitis. Treatment of vaginal candidiasis. Prophylaxis against candidiasis in patients undergoing bone marrow transplantation, or who have received cytotoxic chemotherapy and/or radiation therapy. Treatment of oropharyngeal candidiasis.

Special Pathogen And Immunologic Drug Products

Flucytosine

Serious infections caused by Candida (septicemia, endocarditis and urinary infections).

Special Pathogen And Immunologic Drug Products

Flumazenil

Complete or partial reversal of benzodiazepine overdose, e.g., sedative effects or respiratory depression.

Anesthetic, Critical Care And Addiction Drug Products

Flunisolide

Asthma. Management of symptoms of seasonal or perennial rhinitis.

Pulmonary Drug Products

Fluocinolone

Relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Dermatologic And Dental Drug Products

Fluoxetine

Obsessive compulsive disorder. Treatment of depression.

Neuropharmacological Drug Products

Fluticasone

Maintenance treatment of bronchial asthma. Relief of the symptoms of seasonal or perennial rhinitis.

Pulmonary Drug Products

Fluticasone

Topical treatment of corticosteroid responsive dermatoses.

Dermatologic And Dental Drug Products

Fluvastatin

Heterozygous familial hypercholesterolemia.

Metabolic And Endocrine Drug Products

Fomivirsen Sodium

CMV retinitis.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Foscarnet

Treatment of CMV retinitis in AIDS patients.

Anti-Viral Drug Products

Foscarnet

CMV Retinitis.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Fosinopril

Hypertension.

Cardio-Renal Drug Products

Fosphenytoin

Short-term substitution for oral phenytoin. Prevention and treatment of seizures occurring during neurosurgery. Short-term parenteral administration when other means of phenytoin administration are unavailable, inappropriate, or deemed less advantageous. Control of generalized convulsive status epilepticus.

Neuropharmacological Drug Products

Furazolidine

Specific and symptomatic treatment of bacterial or protozoal diarrhea and enteritis caused by susceptible organisms.

Special Pathogen And Immunologic Drug Products

Furosemide

Treatment of edema (CHF, liver or kidney disease). Treatment of BPD and other forms of chronic lung disease.

Cardio-Renal Drug Products

Gadodiamide

IV administration with magnetic resonance imaging in adult patients to provide contrast enhancement & facilitate visualization of central nervous system, as well as intrathoracic, intra-abdominal, pelvic and retroperitoneal regions of the body.

Medical Imaging And Radiopharmaceutical Drug Products

Gadopentetate

Magnetic resonance imaging contrast medium for adult intracranial tumors(primary or metastatic).

Medical Imaging And Radiopharmaceutical Drug Products

Gadoversetamide

Diagnostic drug for imaging the central nervous system and liver.

Medical Imaging And Radiopharmaceutical Drug Products

Gallium Citrate Ga-67

Useful to demonstrate the following malignancies: Hodgkins disease, lymphomas and bronchogenic carcinoma.

Medical Imaging And Radiopharmaceutical Drug Products

Ganciclovir

CMV prophylaxis in adults (Oral). Life or sight threatening cytomegalovirus infection in immunocompromised patients (Intravenous).

Anti-Viral Drug Products

Ganciclovir Implant

Treatment of cytomegalovirus retinitis.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Gemtuzumab

Treatment of patients with CD-33 positive acute myeloid leukemia.

Oncology Drug Products

Glatiramer

Slowing progression of disability and reducing frequency of relapses in patients with multiple sclerosis.

Neuropharmacological Drug Products

Gold

Juvenile rheumatoid arthritis.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Granisetron

Prevention of chemotherapy-induced emesis.

Gastrointestinal And Coagulation Drug Products

Guanabenz

Hypertension.

Cardio-Renal Drug Products

Guanfacine

Hypertension.

Cardio-Renal Drug Products

Halofantrine

Treatment of mild to moderate acute malaria caused by Plasmodium falciparum or Plasmodium vivax.

Special Pathogen And Immunologic Drug Products

Heparin

Prophylaxis and treatment of thromboembolic conditions (deep venous thrombosis, pulmonary embolism) and disseminated intravascular coagulation; for anticoagulation in blood transfusions, extracorporeal circulation, and dialysis procedures.

Gastrointestinal And Coagulation Drug Products

Human Albumin Microspheres, Octofluoropropane

Opacify the left ventricle and improve the delineation of left ventricular endocardial borders.

Medical Imaging And Radiopharmaceutical Drug Products

Hydralazine

Hypertension.

Cardio-Renal Drug Products

Hydrochlorothiazide

Treatment of edema. Sparing calcium excretion. Hypertension.

Cardio-Renal Drug Products

Hydroflumethiazide

Hypertension.

Cardio-Renal Drug Products

Hydromorphone

For the control of persistent, exhausting cough or dry, nonproductive cough. Epidural administration for pain management. For the relief of moderate to severe pain.

Anesthetic, Critical Care And Addiction Drug Products

Hydroxychloroquine

Juvenile rheumatoid arthritis.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Hydroxyurea

Chronic myelocytic leukemia.

Oncology Drug Products

Ibuprofen/ Hydrocodone

Analgesia.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Ibuprofen/ Pseudoephedrine

Symptoms associated with sinusitis, common cold or flu including nasal congestion, headaches, body aches, pains, and fever.

Over-The-Counter Drug Products

Ibutilide

Conversion of atrial fibrillation and flutter to normal sinus rhythm.

Cardio-Renal Drug Products

Imiglucerase

Long-term enzyme replacement therapy for patients with Type 1 Gaucher disease resulting in one or more of the following: anemia, thrombocytopenia, bone disease or heptomegaly or splenomegaly.

Metabolic And Endocrine Drug Products

Imiquimod

Topical treatment of external anogenital condyloma accuminata.

Dermatologic And Dental Drug Products

Indapamide

Treatment of edema (CHF, liver or kidney disease).

Cardio-Renal Drug Products

Indinavir

Treatment of HIV infection.

Anti-Viral Drug Products

Indium In-111 Pentate Disodium

Radionuclide cisternography.

Medical Imaging And Radiopharmaceutical Drug Products

Indium In-111Oxyquinoline

Radiolabeled autologous leukocytes for the detection of inflammatory process.

Medical Imaging And Radiopharmaceutical Drug Products

Insulin Aspart Recombinant

Treatment of Type 1 diabetes.

Metabolic And Endocrine Drug Products

Iodixanol

Radiographic contrast medium for purposes of angiography and arteriography.

Medical Imaging And Radiopharmaceutical Drug Products

Iofetamine I-123

Radioactive diagnostic-nonlacunar stroke.

Medical Imaging And Radiopharmaceutical Drug Products

Iopromide

Aortography and visceral angiography coronary arteriography/left ventriculography.

Medical Imaging And Radiopharmaceutical Drug Products

Iotrolan

Contrast enhancement for lumbar, thoracic, cervical and total columnar myelography of spinal and subarachnoid spaces.

Medical Imaging And Radiopharmaceutical Drug Products

Ioversol

Radiopaque diagnostic (cerebral angiography and venography, cardiovascular angiography, contrast enhanced computed tomographic imaging of the head and body and excretory urography).

Medical Imaging And Radiopharmaceutical Drug Products

Ioxilan

Computer enhanced computed tomographic imaging of head and body, aortofemoral arteriography, cerebral arteriography, ventriculography.

Medical Imaging And Radiopharmaceutical Drug Products

Ipratropium

Symptomatic relief of rhinorrhea associated with perennial rhinitis. Common cold.

Pulmonary Drug Products

Irbesartan

Hypertension.

Cardio-Renal Drug Products

Iron sucrose

Iron deficiency anemia in chronic hemodialysis patients on erythropoietin.

Gastrointestinal And Coagulation Drug Products

Isoflurane

Anesthesia.

Anesthetic, Critical Care And Addiction Drug Products

Isotretinoin

Treatment of severe recalcitrant nodular acne.

Dermatologic And Dental Drug Products

Isradipine

Hypertension.

Cardio-Renal Drug Products

Itraconazole

Treatment of histoplasmosis and blastomycosis. Antifungal for the treatment of oropharyngeal candidiasis.

Special Pathogen And Immunologic Drug Products

Ketamine

Induction of general anesthesia. Sedation in the intensive care unit. Rapid endotracheal intubation. Epidural pain control. Adjunct in pain management. Premedicant prior to surgery. Premedicant prior to or during a painful procedure.

Anesthetic, Critical Care And Addiction Drug Products

Ketoconazole

Systemic fungal infections.

Special Pathogen And Immunologic Drug Products

Ketoconazole

Dandruff.

Over-The-Counter Drug Products

Ketoconazole

Topical cutaneous candidiasis. Treatment of dermatophytosis. Treatment of seborrheic dermatitis.

Dermatologic And Dental Drug Products

Ketoprofen

Temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, backache, minor pain of arthritis, menstrual cramps; temporary reduction of fever.

Over-The-Counter Drug Products

Ketorolac

Analgesia, pain control.

Anesthetic, Critical Care And Addiction Drug Products

Ketorolac

Treatment of ocular itching associated with allergic conjunctivitis.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Labetalol

Hypertensive emergencies.

Cardio-Renal Drug Products

Lamivudine

Treatment of Hepatitis B. Treatment of HIV infection.

Anti-Viral Drug Products

Lamotrigine

Adjunctive therapy in patients with partial seizures. Conversion to monotherapy in patients with partial seizures who are receiving treatment with a single enzyme inducing anti-epileptic drug.

Neuropharmacological Drug Products

Lansoprazole

Treatment of symptomatic GERD. Treatment of erosive esophagitis.

Gastrointestinal And Coagulation Drug Products

Leflunomide

Juvenile rheumatoid arthritis.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Levalbuterol

Treatment or prevention of bronchospasm in patients with reversible obstructive airway disease.

Pulmonary Drug Products

Levetiracetam

Adjunctive therapy in treatment of partial onset seizures with or without secondary generalization in patients with epilepsy.

Neuropharmacological Drug Products

Levobetaxolol

Lower intraocular pressure.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Levocabastine

Temporary relief of the signs and symptoms of allergic conjunctivitis.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Levocarnitine

Treatment of primary/secondary carnitine deficiency.

Metabolic And Endocrine Drug Products

Levofloxacin

Community-acquired pneumonia. Complicated urinary tract infections. Complicated skin and skin structure infections.

Special Pathogen And Immunologic Drug Products

Linezolid

Vancomycin-Resistant Enterococcus faecium infections, nosocomial pneumonia and complicated skin and skin structure infections.

Anti-Infective Drug Products

Lisinopril

Hypertension.

Cardio-Renal Drug Products

Lithium

Manic phase of bipolar disorder.

Neuropharmacological Drug Products

Loperamide

Controls the symptoms of diarrhea, including travelers diarrhea.

Over-The-Counter Drug Products

Loperamide/ Simethicone

Controls the symptoms of diarrhea and associated gas symptoms.

Over-The-Counter Drug Products

Lopinavir/Ritonavir

Treatment of HIV infection.

Anti-Viral Drug Products

Loracarbef

Pneumonia, sinusitis, UTI. Otitis media, skin and skin structure infections.

Anti-Infective Drug Products

Lorazepam

Sedation during mechanical ventilation. As an anxiolytic. As a premedication prior to a procedure.

Anesthetic, Critical Care And Addiction Drug Products

Lorazepam

Status epilepticus. Anxiety.

Neuropharmacological Drug Products

Losartan

Hypertension.

Cardio-Renal Drug Products

Lovastatin

Heterozygous familial hypercholesterolemia.

Metabolic And Endocrine Drug Products

Magnesium sulfate

Hypertension.

Cardio-Renal Drug Products

Mangafodipir

Indicated for the detection/classification/and diagnostic characterization of hepatic disease during magnetic resonance imaging (MRI).

Medical Imaging And Radiopharmaceutical Drug Products

Manganese

Contrast agent for MRI of the abdomen and pelvis for delineation of the gastrointestinal tract.

Medical Imaging And Radiopharmaceutical Drug Products

Mannitol

Diuresis.

Cardio-Renal Drug Products

Mebendazole

Intestinal worm infestation.

Special Pathogen And Immunologic Drug Products

Mefloquine

Treatment of mild to moderate acute malaria caused by Plasmodium falciparum or Plasmodium vivax.

Special Pathogen And Immunologic Drug Products

Meropenem

Meningitis and intra-abdominal infections.

Anti-Infective Drug Products

Mesalamine

Treatment of active ulcerative proctitis. Treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis, or proctitis. Induction of remission of ulcerative colitis. Maintenance of remission of ulcerative colitis. Treatment of ulcerative colitis.

Gastrointestinal And Coagulation Drug Products

Metaproterenol

For treatment of asthma attacks and reversible bronchospasm.

Pulmonary Drug Products

Methotrexate

Juvenile rheumatoid arthritis.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Methylclothiazide

Hypertension.

Cardio-Renal Drug Products

Methyldopa

Hypertension.

Cardio-Renal Drug Products

Methyldopate

Hypertension.

Cardio-Renal Drug Products

Methylphenidate

ADHD.

Neuropharmacological Drug Products

Metipranolol

Lower intraocular pressure.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Metoclopramide

Prevention of chemotherapy-induced emesis. Prevention of post-operative nausea and vomiting. Treatment of symptomatic GERD.

Gastrointestinal And Coagulation Drug Products

Metolazone

Treatment of refractory edema.

Cardio-Renal Drug Products

Metoprolol

Hypertension.

Cardio-Renal Drug Products

Metronidazole

Anaerobic infections (intra-abdominal, skin and skin structure, gynecologic, bacterial septicemia, bone and joint, lower respiratory tract, and endocarditis).

Special Pathogen And Immunologic Drug Products

Mexiletine

Arrhythmias.

Cardio-Renal Drug Products

Miconazole

Fungal infections.

Special Pathogen And Immunologic Drug Products

Milrinone

Treatment of heart failure.

Cardio-Renal Drug Products

Mirtazepine

Treatment of depression.

Neuropharmacological Drug Products

Misoprostol

Prevention of NSAID induced gastric ulcers in patients at high risk of complications.

Gastrointestinal And Coagulation Drug Products

Mivacurium

Facilitate tracheal intubation. Provide skeletal muscle relaxation during surgery or mechanical ventilation.

Anesthetic, Critical Care And Addiction Drug Products

Modafanil

Treatment of narcolepsy.

Neuropharmacological Drug Products

Moexipril

Hypertension.

Cardio-Renal Drug Products

Mometasone

Corticosteroid responsive dermatoses.

Dermatologic And Dental Drug Products

Mometasone

Prophylaxis and treatment of seasonal allergic rhinitis and treatment of symptoms of perennial rhinitis.

Pulmonary Drug Products

Montelukast

Prophylaxis and chronic treatment of asthma.

Pulmonary Drug Products

Morphine

By epidural, caudal route for postoperative pain management. By continuous infusion in the critical care setting. As a premedicant prior to general anesthesia. By continuous or intermittent administration by patient controlled analgesia for acute or chronic pain syndromes. Subarachnoid for postoperative pain management. Intra-articular. Oral route for cancer pain. As an adjunct to general anesthesia prior to or during general anesthesia.

Anesthetic, Critical Care And Addiction Drug Products

Mupirocin

Eradication of methicillin resistant S. aureus during institutional outbreaks.

Anti-Infective Drug Products

Nabumetone

Juvenile rheumatoid arthritis.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Nadolol

Hypertension.

Cardio-Renal Drug Products

Nafcillin

Severe infections due to penicillinase producing staphylococci.

Anti-Infective Drug Products

Nalbuphine

Treatment of nausea and itching from epidural opioids. Epidural pain management. As an adjunct to general anesthesia for postoperative pain management. Analgesia prior to or during a painful procedure.

Anesthetic, Critical Care And Addiction Drug Products

Naltrexone

For treatment of opiate dependence.

Anesthetic, Critical Care And Addiction Drug Products

Naproxen Sodium

Analgesia, antipyresis.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Naratriptan

Acute treatment of migraine (with or without aura).

Neuropharmacological Drug Products

Nedocromil

Maintenance therapy in the management of patients with mild to moderate asthma.

Pulmonary Drug Products

Nefazodone

Treatment of depression.

Neuropharmacological Drug Products

Nelfinavir

Treatment of HIV infection.

Anti-Viral Drug Products

Nevirapine

Treatment of HIV infection.

Anti-Viral Drug Products

Nicardipine

Hypertension.

Cardio-Renal Drug Products

Nicotine

Temporary nicotine replacement for facilitating smoking cessation with or without a behavioral and/or psychological modification program.

Anesthetic, Critical Care And Addiction Drug Products

Nicotine

To reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking.

Over-The-Counter Drug Products

Nifedipine

Hypertension.

Cardio-Renal Drug Products

Nisoldipine

Hypertension.

Cardio-Renal Drug Products

Nitroglycerin

Hypertension.

Cardio-Renal Drug Products

Nitroprusside

Treatment of heart failure. Emergency use in hypertensive emergencies.

Cardio-Renal Drug Products

Nizatidine

Erosive esophagitis. Treatment of symptomatic GERD. Treatment of ulcer disease.

Gastrointestinal And Coagulation Drug Products

Norfloxacin

Complicated urinary tract infections.

Special Pathogen And Immunologic Drug Products

Norfloxacin

Superficial infections of the eye caused by strains susceptible to norfloxacin.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Ofloxacin

Treatment of ocular infections.

Anti-Inflammatory, Analgesic, And Ophthalmologic Drug Products

Olanzapine

Management of the manifestations of psychotic disorders.

Neuropharmacological Drug Products

Olsalazine

Maintenance of remission of ulcerative colitis in patients intolerant of sulfasalazine.

Gastrointestinal And Coagulation Drug Products

Omeprazole

Treatment of symptomatic GERD. Treatment of erosive esophagitis.

Gastrointestinal And Coagulation Drug Products

Ondansetron

Prevention of chemotherapy-induced emesis. Treatment of post-operative nausea and vomiting. Prevention of post-operative nausea and vomiting.

Gastrointestinal And Coagulation Drug Products

Orlistat

Obesity management and reduction of the risk of weight gain.

Metabolic And Endocrine Drug Products

Oseltamivir

Treatment of Influenza A and B.

Anti-Viral Drug Products

Oxacillin

Infections due to penicillinase producing staphylococci.

Anti-Infective Drug Products

Oxazepam

Anxiety.

Neuropharmacological Drug Products

Oxcarbazepine

Adjunctive therapy in treatment of partial seizures with or without secondary generalization in patients with epilepsy.

Neuropharmacological Drug Products

Oxycodone

Management of pain.

Anesthetic, Critical Care And Addiction Drug Products

Pancrelipase

Chronic pancreatitis.

Gastrointestinal And Coagulation Drug Products

Pancuronium

Neuromuscular blocking agent.

Anesthetic, Critical Care And Addiction Drug Products

Pantoprazole

Short-term treatment of erosive esophagitits associated with GERD.

Gastrointestinal And Coagulation Drug Products

Paricalcitol

Prevention and treatment of secondary hyperparathyroidism associated with chronic renal failure.

Metabolic And Endocrine Drug Products

Paroxetine

Treatment of depression. Obsessive compulsive disorder.

Neuropharmacological Drug Products

Pemoline

ADHD.

Neuropharmacological Drug Products

Penbutolol

Hypertension.

Cardio-Renal Drug Products

Penciclovir

Recurrent herpes labialis.

Anti-Viral Drug Products

Pentamadine

Prevention of Pneumocystis carnii infection.

Special Pathogen And Immunologic Drug Products

Perindopril

Hypertension.

Cardio-Renal Drug Products

Permethrin

Treatment of pediculus humanus capitis (head lice) infestation.

Over-The-Counter Drug Products