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U.S. Department of Health and Human Services

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Efficacy Supplement Approvals in 1998

ENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPPLEMENT TYPE TOTAL APPROVAL TIME (MONTHS) INDICATION / DESCRIPTION
               
ACARBOSE BAYER 20-482 30-Sep-97 29-Sep-98 SE1 12.0 For patients with type 2 diabetes treated with diet plus insulin.
ACARBOSE BAYER 20-482 25-Nov-97 29-Sep-98 SE1 10.1 For patients with type 2 diabetes treated with diet plus metformin.
ACYCLOVIR SODIUM GLAXO WELCOME 18-603 02-Jun-97 02-Jun-98 SE1 12.0 Treatment of herpes simplex virus infections in neonatal patients.
ALBUTEROL SULFATE 3M PHARMACEUTICALS 20-503 26-Sep-97 23-Sep-98 SE1 11.9 Prevention of exercise-induced bronchospasm in patients 12 years of age and older.
AMOXICILLIN SMITHKLINE BEECHAM 50-542 06-Oct-97 27-Feb-98 SE1 4.7 For use in combination with lansoprazole (with or without clarithromycin) in patients with duodenal ulcer (defined as an active ulcer or history of an ulcer within one year) to eradicate Helicobacter pylori and reduce the risk of duodenal ulcer recurrence.
ANAGRELIDE HYDROCHLORIDE ROBERTS LABS 20-333 02-Jan-98 16-Dec-98 SE1 11.4 Treatment of patients with thrombocythemia, secondary to myeloproliferative disorders, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events.
ANASTROZOLE ZENECA PHARMS 20-541 10-Feb-97 06-Feb-98 SLR 11.9 Treatment of advanced breast cancer in postmenopausal women who have progressed following tamoxifen therapy.
APROTININ BAYER 20-304 06-Nov-96 28-Aug-98 SE1 21.7 Prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery.
ATORVASTATIN CALCIUM WARNER LAMBERT 20-702 17-Jul-97 10-Jul-98 SE1 11.8 Adjunctive therapy to diet for the treatment of patients with elevated serum primary triglyceride levels (Frederickson Type IV).
ATORVASTATIN CALCIUM WARNER LAMBERT 20-702 23-Jul-97 10-Jul-98 SE1 11.6 Use by patients with primary dysbetalipoproteinemia (Frederickson Type III) who do not respond adequately to diet.
AZTREONAM BRISTOL MYERS SQUIBB 50-632 29-Dec-97 24-Dec-98 SE1 11.8 Pediatric use statement added to labeling for treatment of infections caused by susceptible gram-negative microorganisms.
BUDESONIDE ASTRA PHARMS 20-441 08-Oct-97 08-Oct-98 SE2 12.0 Once daily dosing for maintenance therapy of mild to moderate asthma and for initiation of therapy.
CALCITRIOL ROCHE 18-044 20-Nov-97 20-Nov-98 SE1 12.0 Treatment of secondary hyperparathyroidism in patients (including pediatric patients) with moderate to severe chronic renal failure who are not yet undergoing dialysis.
CEFEPIME HYDROCHLORIDE BRISTOL MYERS SQUIBB 50-679 31-Jan-97 30-Jan-98 SE1 12.0 Additional use in combination with metronidazole for the treatment of complicated intra-abdominal infections.
CEFPODOXIME PROXETIL PHARMACIA AND UPJOHN 50-674 22-Jan-98 20-Nov-98 SE1 9.9 Treatment of acute maxillary sinusitis.
CEFPODOXIME PROXETIL PHARMACIA AND UPJOHN 50-675 22-Dec-97 20-Nov-98 SE2 10.9 5-day treatment of otitis media in pediatric patients.
CEFPODOXIME PROXETIL PHARMACIA AND UPJOHN 50-675 22-Jan-98 20-Nov-98 SE1 9.9 Treatment of acute maxillary sinusitis.
CETIRIZINE HYDROCHLORIDE PFIZER 19-835 03-Jun-97 15-May-98 SE1 11.4 Use in pediatric patients 2 to 5 years of age for seasonal and perennial allergic rhinitis and chronic idiopathic urticaria.
CETIRIZINE HYDROCHLORIDE PFIZER 20-346 16-May-97 15-May-98 SE1 12.0 Use in pediatric patients 2 to 5 years of age for seasonal and perennial allergic rhinitis and chronic idiopathic urticaria.
CILASTATIN SODIUM/IMIPENEM MERCK 50-587 08-Apr-97 08-Apr-98 SE5 12.0 Treatment of serious infections caused by susceptible strains of designated microorganisms in pediatric patients.
CIMETIDINE SKB CONS HLTHCARE 20-238 06-Jun-97 05-Jun-98 SE2 12.0 Revises the dosage directions for the prevention of meal-induced heartburn from "…take one tablet 30 minutes before eating…" to "…take one tablet just before or anytime up to 30 minutes before eating…".
CIPROFLOXACIN BAYER 19-847 22-Dec-95 03-Apr-98 SE5 27.4 Provides for the addition of information to the Pediatric Use subsection of the labeling pertaining to the use in cystic fibrosis patients.
CIPROFLOXACIN BAYER 19-857 22-Dec-95 03-Apr-98 SE5 27.4 Provides for the addition of information to the Pediatric Use subsection of the labeling pertaining to the use in cystic fibrosis patients.
CIPROFLOXACIN BAYER 19-858 27-Dec-95 03-Apr-98 SE5 27.2 Provides for the addition of information to the Pediatric Use subsection of the labeling pertaining to the use in cystic fibrosis patients.
CIPROFLOXACIN BAYER 19-847 08-Oct-97 24-Sep-98 SE1 11.5 Treatment of acute sinusitis and chronic bacterial prostatitis infections.
CIPROFLOXACIN BAYER 19-847 08-Oct-97 24-Sep-98 SE1 11.5 Treatment of acute sinusitis and chronic bacterial prostatitis infections.
CIPROFLOXACIN BAYER 19-857 08-Oct-97 24-Sep-98 SE1 11.5 Treatment of acute sinusitis and chronic bacterial prostatitis infections.
CIPROFLOXACIN BAYER 19-857 08-Oct-97 24-Sep-98 SE1 11.5 Treatment of acute sinusitis and chronic bacterial prostatitis infections.
CIPROFLOXACIN BAYER 19-858 08-Oct-97 24-Sep-98 SE1 11.5 Treatment of acute sinusitis and chronic bacterial prostatitis infections.
CIPROFLOXACIN BAYER 19-858 08-Oct-97 24-Sep-98 SE1 11.5 Treatment of acute sinusitis and chronic bacterial prostatitis infections.
CIPROFLOXACIN HYDROCHLORIDE BAYER 19-537 27-Dec-95 03-Apr-98 SE5 27.2 Provides for the addition of information to the Pediatric Use subsection of the labeling pertaining to the use in cystic fibrosis patients.
CISATRACURIUM BESYLATE GLAXO WELLCOME 20-551 24-Oct-97 15-Oct-98 SE8 11.7 Adjunct to general anesthesia, to facilitate tracheal intubation, and provide skeletal muscle relaxation during surgery or mechanical ventilation in the ICU.
CISATRACURIUM BESYLATE GLAXO WELLCOME 20-551 19-Jun-97 19-Jun-98 SLR 12.0 Adjunct to general anesthesia, to facilitate tracheal intubation, and provide skeletal muscle relaxation during surgery or mechanical ventilation in the ICU.
CLARITHROMYCIN ABBOTT LABS 50-662 12-Nov-97 16-Sep-98 SE1 10.1 For the use in combination with omeprazole and amoxicillin, as triple therapy for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or one-year history of duodenal ulcer) to eradicate Helicobacter pylori.
CLINDAMYCIN PHOSPHATE PHARMACIA AND UPJOHN 50-680 08-May-95 02-Mar-98 SE2 33.8 Provides for a 3-day dosing regimen of 2% clindamycin phosphate vaginal cream in the treatment of bacterial vaginosis.
DESMOPRESSIN ACETATE RHONE POULENC RORER 19-955 26-Mar-97 25-Mar-98 SE1 12.0 Primary nocturnal enuresis.
DEXTROSE ABBOTT LABS 19-445 25-Nov-97 23-Nov-98 SE5 11.9 Provides for a new Sub-population - Neonates and older infants for approved use as a minimal source of carbohydrates and calories in this population.
DEXTROSE ABBOTT LABS 19-445 25-Nov-97 23-Nov-98 SE1 11.9 Provides for a new indication in the treatment acute symptomatic episodes of hypoglycemia in the neonate and older infant to restore depressed blood glucose levels and control symptoms.
DICLOFENAC SODIUM CIBA VISION CORP 20-037 30-Sep-96 25-Feb-98 SE1 16.9 For the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery.
DILTIAZEM HYDROCHLORIDE BIOVAIL LABS 20-401 30-Jan-97 30-Jan-98 SE1 12.0 Treatment of chronic stable angina.
DOCETAXEL RHONE POULENC RORER 20-449 22-Dec-97 22-Jun-98 SE7 6.0 Treatment in patients with locally advanced or metastatic breast carcinoma in whom previous therapy has failed.
ENOXAPARIN SODIUM RHONE POULENC RORER 20-164 01-Apr-96 30-Jan-98 SE1 22.0 Prevention (during and following hospitalization) of deep vein thrombosis, which may lead to pulmonary embolism, in patients undergoing hip replacement surgery.
ENOXAPARIN SODIUM RHONE POULENC RORER 20-164 18-Mar-97 27-Mar-98 SE1 12.3 Prevention of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin.
ENOXAPARIN SODIUM RHONE POULENC RORER 20-164 28-Feb-97 31-Dec-98 SE1 22.1 Inpatient treatment of acute deep vein thrombosis with and without pulmonary embolism, when administered in conjunction with warfarin sodium; and for the outpatient treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium.
EPROSARTAN MESYLATE SKB PHARMS 20-738 26-Jan-98 28-Oct-98 SE2 9.0 Once daily dosing regimen for the treatment of essential hypertension.
ESTROGENS, CONJUGATED WYETH AYERST LABS 04-782 22-Feb-94 08-Sep-98 SE2 54.5 Prevention of osteoporosis.
ESTROGENS/ CONJUGATED MEDROXYPRO-GESTERONE ACETATE WYETH AYERST LABS 20-527 09-Jan-97 09-Jan-98 SE2 12.0 Treatment of moderate to severe vasomotor symptoms associated with the menopause; treatment of vulvar and vaginal atrophy; prevention of osteoporosis.
ETIDRONATE DISODIUM MGI 19-545 28-Dec-94 01-Apr-98 SLR 39.1 Treatment of hypercalcemia of malignancy inadequately managed by dietary modification and/or oral hydration.
FAMCICLOVIR SMITHKLINE BEECHAM 20-363 13-Jun-97 12-Jun-98 SE1 11.2 Treatment of recurrent mucocutaneous herpes simplex infections in HIV-infected patients at a dose of 500mg twice daily.
FAMOTIDINE MERCK 20-325 23-Dec-96 09-Nov-98 SE2 22.6 Relief of heartburn associated with acid indigestion and sour stomach and for prevention of heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.
FINASTERIDE MERCK 20-180 19-May-97 20-Mar-98 SE5 10.0 Treatment of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.
FINASTERIDE MERCK 20-180 22-Sep-97 20-Mar-98 SE1 5.9 Treatment of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy..
FLUTICASONE PROPIONATE GLAXO WELLCOME 20-121 18-Dec-97 11-Dec-98 SE1 11.8 Treatment of nasal symptoms of perennial nonallergic rhinitis in adults and pediatric patients 4 years and older.
GABAPENTIN PARKE DAVIS PHARMS 20-235 16-Sep-96 29-Sep-98 SE2 24.4 Adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults with epilepsy.
GEMCITABINE HYDROCHLORIDE LILLY 20-509 29-Aug-97 25-Aug-98 SE1 11.9 In combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer.
GLIPIZIDE PFIZER 20-329 03-Jul-97 04-Feb-98 SE1 7.1 Provides for combination therapy with metformin when satisfactory lowering of blood glucose is not achieved with Gulcotrol XL alone.
GOSERELIN ACETATE ZENECA (UK) 20-578 12-Aug-97 27-Jul-98 SE1 11.5 Provides for the use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate.
GOSERELIN ACETATE ZENECA PHARMS 19-726 09-Apr-97 09-Apr-98 SE1 12.0 Palliative treatment of advanced carcinoma of the prostate; management of endometriosis.
GOSERELIN ACETATE ZENECA PHARMS 19-726 12-Aug-97 27-Jul-98 SE1 11.5 In combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate.
HYDROXYUREA BRISTOL MYERS SQUIBB 16-295 12-May-97 25-Feb-98 SE1 9.5 To reduce the frequency of painful crises and to reduce the need for blood transfusions in adult patients with sickle cell anemia with recurrent moderate to severe painful crises (generally at least 3 during the preceding 12 months).
INDINAVIR SULFATE MERCK RES 20-685 16-Sep-97 06-Feb-98 SE1 4.7 Treatment of HIV infection in combination with antiretroviral agents.
INTERFERON ALFA-2B, RECOMBINANT/ RIBAVIRIN SCHERING PLOUGH RES 20-903 17-Jun-98 09-Dec-98 SE5 5.8 Combination therapy for chronic hepatitis C in patients with compensated liver disease previously untreated with alpha interferon therapy.
IPRATROPIUM BROMIDE BOEHRINGER INGELHEIM 20-393 01-Apr-97 01-Apr-98 SE1 12.0 Symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in children age 6 to 11 years.
IPRATROPIUM BROMIDE BOEHRINGER INGELHEIM 20-394 19-Dec-97 09-Nov-98 SE1 10.7 Symptomatic relief of rhinorrhea associated with the common cold in children age 5 to 11 years.
IRINOTECAN HYDROCHLORIDE PHARMACIA AND UPJOHN 20-571 22-Apr-98 22-Oct-98 SE7 6.0 Treatment of patients with metastatic carcinoma on the colon or rectum whose disease has recurred or progressed following 5-FU-based therapy.
ISOCARBOXAZID HOFFMANN-LA ROCHE 11-961 28-Aug-81 18-Aug-98 SE1 203.8 Second line treatment of depression.
LAMIVUDINE GLAXO WELLCOME 21-003 24-Jun-98 08-Dec-98 N 5.5 Treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation.
LAMIVUDINE GLAXO WELLCOME 21-004 30-Jun-98 08-Dec-98 N 5.3 Treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation.
LAMOTRIGINE GLAXO WELLCOME 20-241 17-Sep-96 24-Aug-98 SE1 23.2 Adjunctive treatment of Lennox-Gastaut syndrome in pediatric and adult patients.
LAMOTRIGINE GLAXO WELLCOME 20-241 25-Feb-97 14-Dec-98 SE1 21.6 For conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme-inducing anti-epileptic drug (EIAED)
LAMOTRIGINE GLAXO WELLCOME 20-764 08-Sep-98 14-Dec-98 SE1 3.2 For conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme-inducing anti-epileptic drug (EIAED)
LANSOPRAZOLE TAP HOLDINGS 20-406 23-Dec-96 12-Mar-98 SE1 14.6 Short-term treatment of symptomatic gastroesophageal reflux disease (GERD).
LANSOPRAZOLE TAP HOLDINGS 20-406 26-Jun-97 20-Jul-98 SE2 12.8 10-day dosing regimen for triple therapy, in combination with clarithromycin and amoxicillin, for the eradication of Helicobacter pylori in patients with duodenal ulcer disease.
LEUPROLIDE ACETATE TAP HOLDINGS 20-011 23-Sep-97 09-Apr-98 SE1 6.5 Management of endometriosis; preoperative management of uterine fibroids.
LEVOFLOXACIN JOHNSON RW 20-635 04-Jun-98 17-Dec-98 SE1 6.4 Treatment of uncomplicated urinary tract infections (UTI).
LEVOFLOXACIN JOHNSON RW 20-634 04-Jun-98 17-Dec-98 SE1 6.4 Treatment of uncomplicated urinary tract infections (UTI).
LIDOCAINE/ PRILOCAINE ASTRA PHARMS 19-941 25-Feb-97 04-Feb-98 SE4 11.3 Pre-procedural application to adult male genital skin prior to site-specific subcutaneous infiltration with lidocaine for the removal of genital warts.
LOTEPREDNOL ETABONATE PHARMOS 20-841 02-May-97 09-Mar-98 N 10.2 Post-operative inflammation following ocular surgery.
MEDROXYPRO-GESTERONE ACETATE PHARMACIA AND UPJOHN 11-839 04-Aug-97 04-Aug-98 SE1 12.0 Reduction of endometrial hyperplasia in postmenopausal women.
METFORMIN HYDROCHLORIDE BRISTOL MYERS SQUIBB 20-357 23-Apr-98 22-Oct-98 SE1 6.0 New combination use of metformin and insulin in type 2 diabetes.
METHOHEXITAL SODIUM ELI LILLY 11-559 17-Dec-96 30-Jan-98 SE3 13.4 For rectal use in pediatric patients.
METHOHEXITAL SODIUM ELI LILLY 11-559 17-Dec-96 30-Jan-98 SE3 13.4 Intramuscular use in pediatric patients.
MIVACURIUM CHLORIDE GLAXO WELLCOME 20-098 20-May-97 19-May-98 SLR 12.0 Adjunct to general anesthesia to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
MOMETASONE FUROATE SCHERING PLOUGH 20-762 27-Oct-97 18-Nov-98 SE8 12.7 Prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis and the treatment of the nasal symptoms of perennial allergic rhinitis, in adults and children 12 years of age and older.
MYCOPHENOLATE MOFETIL SYNTEX 50-722 12-Aug-97 11-Feb-98 SE1 6.0 Prophylaxis of organ rejection in patients receiving allogeneic cardiac transplant.
NAFARELIN ACETATE SEARLE PHARMS 19-886 24-Dec-97 24-Dec-98 SE8 12.0 Revisions to the Clinical Pharmacology and Adverse Reactions sections of the labeling for the treatment of symptoms associated with endometriosis.
NEFAZODONE HYDROCHLORIDE BRISTOL MYERS SQUIBB 20-152 02-Apr-97 31-Mar-98 SLR 11.9 For the maintenance treatment of depression and in the treatment of depressed inpatients.
NEVIRAPINE BOEHRINGER PHARMS 20-636 04-Jun-97 20-May-98 SE1 11.5 In combination with other antiretroviral agents for the treatment of HIV-1 infection.
NEVIRAPINE BOEHRINGER PHARMS 20-636 16-Mar-98 11-Sep-98 SE1 5.9 Inclusion of pediatric information in the labeling for use in combination therapy with other antiretroviral agents for the treatment of HIV-1 infection.
NICOTINE ELAN 19-983 24-Sep-98 23-Dec-98 SE6 3.0 Adjunct in smoking cessation for those patients experiencing difficulty due to nicotine addiction.
NICOTINE POLACRILEX SMITHKLINE BEECHAM 18-612 18-May-98 23-Dec-98 SE4 7.2 Over-the-counter (OTC) marketing of mint flavored Nicorette 2 mg and 4 mg gum for use by adults only.
NICOTINE POLACRILEX SMITHKLINE BEECHAM 20-066 18-May-98 23-Dec-98 SE4 7.2 Over-the-counter (OTC) marketing of mint flavored Nicorette 2 mg and 4 mg gum for use by adults only.
NIZATIDINE WHITEHALL ROBINS 20-555 17-Dec-96 01-Apr-98 SE1 15.5 Treatment of episodic heartburn, acid indigestion and sour stomach.
NIZATIDINE WHITEHALL ROBINS 20-555 01-Apr-97 01-Apr-98 SE2 12.0 Revision to the Directions section of the labeling to change the time to take the drug prior to a meal to prevent meal-induced heartburn symptoms from "…one-half to one hour before eating…" to "…right before eating or up to 60 minutes before consuming...".
OMEPRAZOLE ASTRA MERCK 20-916 30-Sep-97 29-Jun-98 N 8.9 Concomitant use with amoxicillin and clarithromycin for the eradication of Helicobacter pylori in patients with duodenal ulcer disease.
OMEPRAZOLE ASTRA MERCK 19-810 15-Apr-98 30-Jun-98 SE8 2.5 Concomitant use with amoxicillin and clarithromycin for the eradication of Helicobacter pylori in patients with duodenal ulcer disease.
PACLITAXEL BRISTOL MYERS SQUIBB 20-262 09-Oct-97 09-Apr-98 SE1 6.0 First-line therapy for the treatment of advanced carcinoma of the ovary in combination with cisplatin.
PACLITAXEL BRISTOL MYERS SQUIBB 20-262 30-Jun-97 30-Jun-98 SE1 12.0 In combination with cisplatin for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.
PAMIDRONATE DISODIUM NOVARTIS PHARMS 20-927 22-Sep-97 22-Sep-98 N 12.0 In conjunction with standard antineoplastic therapy for the treatment of osteolytic bone metastases of breast cancer.
PENTAZOCINE LACTATE ABBOTT LABS 16-194 02-Jan-98 22-Oct-98 SE8 9.6 Relief of moderate to severe pain for pediatric use.
PILOCARPINE HYDROCHLORIDE MGI 20-237 12-Feb-97 11-Feb-98 SE1 12.0 Treatment of symptoms of dry mounth in patients with Sjogren's syndrome.
PORFIMER SODIUM QLT 20-451 10-Feb-97 09-Jan-98 SE1 10.9 Photodynamic therapy for treatment of microinvasive endobronchial non-small cell lung cancer in patients for whom surgery and radiotherapy are not indicated.
PORFIMER SODIUM QLT 20-451 10-Feb-97 22-Dec-98 SE1 22.4 Photodynamic therapy for reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial non-small cell lung cancer.
PRAVASTATIN SODIUM BRISTOL MYERS SQUIBB 19-898 02-Sep-97 11-Mar-98 SE1 6.2 Reduction of triglycerides as a new indication.
PRAVASTATIN SODIUM BRISTOL MYERS SQUIBB 19-898 31-Mar-97 27-Mar-98 SE1 11.9 For use in patients with previous myocardial infarction(MI) and normal cholesterol levels, to reduce risk of recurrent MI, myocardial revascularization, and cerebrovascular disease events.
PREDNISOLONE SODIUM PHOSPHATE MEDEVA PHARMS 19-157 07-Apr-97 17-Dec-98 SE5 20.4 For pediatric use.
RALOXIFENE HYDROCHLORIDE LILLY 20-815 27-Jul-98 24-Nov-98 SE8 3.9 Prevention of postmenopausal osteoporosis.
RANITIDINE BISMUTH CITRATE GLAXO WELLCOME 20-559 01-Apr-97 23-Mar-98 SE2 11.7 Allows for a reduction in the dosing frequency of clarithromycin when used for the approved indication. Tritec in combination with clarithromycin is indicated for the treatment of patients with an active duodenal ulcer associated with Helicobacter pylori infection.
RANITIDINE HYDROCHLORIDE GLAXO WELLCOME 20-520 06-Nov-96 08-Jun-98 SE1 19.0 Prevention of meal-induced heartburn when taken 30 to 60 minutes prior to a provocative meal.
SALMETEROL XINAFOATE GLAXO WELLCOME 20-236 27-Mar-97 05-Feb-98 SE1 10.4 Long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
SALMETEROL XINAFOATE GLAXO WELLCOME 20-692 26-Sep-97 25-Sep-98 SE1 12.0 Treatment of exercise-induced bronchospasm in adults and children 4 years of age and older with reversible obstructive airway disease.
SALMETEROL XINAFOATE GLAXO WELLCOME 20-692 26-Sep-97 25-Sep-98 SE5 12.0 Maintenance treatment of asthma and prevention of bronchospasm in adults and children 4 years of age and older.
SIMVASTATIN MERCK 19-766 14-Aug-97 31-Mar-98 SE1 7.5 To reduce the risk of stroke or transient ischemic attack.
SIMVASTATIN MERCK 19-766 05-Aug-97 10-Jul-98 SE1 11.1 Treatment of patients with homozygous familial hypercholesterolemia.
SIMVASTATIN MERCK 19-766 05-Aug-97 10-Jul-98 SE2 11.1 New dosage strength and dosing regimen (80 mg per day).
SUMATRIPTAN SUCCINATE GLAXO WELLCOME 20-132 18-Feb-97 13-Feb-98 SE2 11.8 Revision to the recommended usual adult dose.
TAMOXIFEN CITRATE ZENECA PHARMS 17-970 28-Jan-98 29-Oct-98 SE1 9.0 Reduce the occurrence of contralateral breast cancer in patients receiving adjuvant Nolvadex therapy for breast cancer.
TAMOXIFEN CITRATE ZENECA PHARMS 17-970 30-Apr-98 29-Oct-98 SE1 6.0 For reducing the incidence of breast cancer in women at high risk breast cancer.
TOPOTECAN HYDROCHLORIDE SMITHKLINE BEECHAM 20-671 05-Dec-97 30-Nov-98 SE1 11.8 Treatment of small cell lung cancer sensitive disease after failure of first-line chemotherapy.
TORSEMIDE BOEHRINGER MANNHEIM 20-137 27-Nov-96 13-Feb-98 SE2 14.6 Continuous infusion as an alternate method of administration.
TRAMADOL HYDROCHLORIDE JOHNSON RW 20-281 22-Aug-97 21-Aug-98 SE1 12.0 Provides for the addition in the dosage and administration section of the labeling.
TRIPELENNAMINE HYDROCHLORIDE NOVARTIS PHARMS 10-533 22-Mar-83 20-Mar-98 SE1 180.1 Provides for updated labeling in accordance with September 1977 DESI FR notice.
TRIPELENNAMINE HYDROCHLORIDE NOVARTIS PHARMS 05-914 22-Mar-83 24-Mar-98 SE1 180.2 Provides for updated labeling in accordance with September 1977 DESI FR notice.
VANCOMYCIN HYDROCHLORIDE BAXTER HLTHCARE 50-671 17-Dec-96 08-Jan-98 SE5 12.7 Provides for specific dosing of premature neonates.