What's New by Date

This page lists new and revised documents posted to the CDER web site. Each listing will remain on this page approximately 30 days. The dates listed indicate the dates of posting to the CDER web site, not the dates of origination or revision. When viewing a document, click your browser's "refresh" or "reload" button to make sure you are seeing the latest version.

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May 16, 2008

• FDA approves new Medication Guide and Label for Varenicline (marketed as Chantix). Drug Information.
• FDA issues an FDA Alert and Information for Healthcare Professional sheet for Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic). Drug Information.
• New and Generic Drug Approvals
  • Chantix (varenicline tartrate) Tablet, Pfizer Inc., Labeling Revision
• Warning Letter: Nasim Golzar, MD

May 15, 2008

• Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
• Manual of Policies and Procedures (MaPPs) 7500.1R Office of New Drugs Regulatory Project Management Coordinating Committee (Issued 5/15/2008, Posted 5/15/2008)

May 14, 2008

• Aprotinin Injection (marketed as Trasylol): Manufacturer Removes Remaining Stocks of Trasylol. FDA News and Information.
• Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book
• Drugs@FDA Downloadable Data Files (updated)
• FDA releases a Follow-up to the November 14, 2007, Communication about the Ongoing Safety Review of Cefepime (marketed as Maxipime).
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass
• New and Generic Drug Approvals
  • Cyclobenzaprine Hydrochloride Tablets, Ranbaxy, Inc., Approval
  • Definity (perflutren) Injection, Lantheus Medical Imaging, Labeling Revision
  • Flumazenil Injection, Akorn-Strides, LLC., Approval
  • Haldol (haloperidol decanoate) Injection, Ortho McNeil Pharmaceutical, Labeling Revision
  • Haldol (haloperidol lactate) Injection, Ortho McNeil Pharmaceutical, Labeling Revision
  • Lariam (mefloquine hydrochloride) Tablets, Hoffmann-La Roche, Inc., Labeling Revision
  • Lidocaine Hydrochloride and Epinephrine Injection, Hospira, Inc., Approval
  • Probenecid and Colchicine Tablets, Concord Laboratories, Inc., Approval
  • Ramipril Capsules, Lupin Pharmaceuticals, Inc., Tentative Approval
  • Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision
  • Seroquel (quetiapine fumarate) Tablets, AstraZeneca Pharmaceuticals LP, New or Modified Indication
  • Valium (diazepam) Tablets, Roche Products, Labeling Revision

May 13, 2008

• CDER Organization Charts [HTML] [PDF] (updated)
• Drug Safety Oversight Board Meeting, April 17, 2008, Public Summary
• New and Generic Drug Approvals
  • Ceftriaxone and Dextrose in Duplex Container Injection, B. Braun Medical, Inc., Labeling Revision
  • Children's Cetirizine Hydrochloride Allergy Syrup, Actavis Mid-Atlantic, LLC, Tentative Approval
  • Children's Cetirizine Hydrochloride Hives Relief Syrup, Actavis Mid-Atlantic, LLC, Tentative Approval
  • Desmopressin Acetate Tablets, Ferring Pharmaceuticals, Inc., Approval
  • Drospirenone and Ethinyl Estradiol Tablets, Barr Laboratories, Inc., Approval
  • Emtricitabine Capsules, Aurobindo Pharma USA, Inc., Tentative Approval
  • Myfortic (mycophenolic acid) Delayed-Release Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  • OraVerse (phentolamine mesylate) Injection, Novalar Pharmaceuticals, Inc., Approval
  • Primaxin I.M. (imipenem and cilastatin sodium) Injection, Merck & Co., Labeling Revision
  • Primaxin I.V. (imipenem and cilastatin sodium) Injection, Merck & Co., Labeling Revision
  • TACLONEX SCALP (calcipotriene and betamethasone dipropionate) Topical Suspension, Leo Pharmaceutical Products, Ltd., Approval
  • Timentin (ticarcillin disodium and clavulanate potassium) Injection, GlaxoSmithKline, Labeling Revision
  • Timentin in Plastic Container (ticarcillin disodium and clavulanate potassium) Injection, GlaxoSmithKline, Labeling Revision

May 12, 2008

• Drug Shortage: Digitek (digoxin tablets, USP)
• FDA requests that health professionals and facilities review and examine all drug/device storage areas to ensure that all recalled heparin products have been removed and are no longer available for patient use. MedWatch Safety Information
• New and Generic Drug Approvals
  • Abilify (aripiprazole) Orally Disintegrating Tablet, Otsuka Pharmaceutical Co., Ltd., New Dosage Regimen
  • Abilify (aripiprazole) Orally Disintegrating Tablet, Otsuka Pharmaceutical Co., Ltd., New or Modified Indication
  • Abilify (aripiprazole) Intramuscular Injection, Otsuka Pharmaceutical Co., Ltd., New Dosage Regimen
  • Abilify (aripiprazole) Intramuscular Injection, Otsuka Pharmaceutical Co., Ltd., New or Modified Indication
  • Abilify (aripiprazole) Tablet, Otsuka Pharmaceutical Co., Ltd., New Dosage Regimen
  • Abilify (aripiprazole) Tablet, Otsuka Pharmaceutical Co., Ltd., New or Modified Indication
  • Abilify (aripiprazole) Oral Solution, Otsuka Pharmaceutical Co., Ltd., New Dosage Regimen
  • Abilify (aripiprazole) Oral Solution, Otsuka Pharmaceutical Co., Ltd., New or Modified Indication
  • Acarbose Tablets, Roxane Laboratories, Inc., Approval
  • Acarbose Tablets, Cobalt Laboratories, Approval
  • Actos (pioglitazone hydrochloride), Tablets, Takeda Global Research & Development Center, Inc., Labeling Revision
  • Ambien (zolpidem tartrate) Tablets, Sanofi-Synthelabo Research, Labeling Revision
  • Betoptic S (betaxolol hydrochloride) Ophthalmic Suspension, Alcon, Labeling Revision
  • Calcipotriene Topical Solution, Nycomed US, Inc., Approval
  • Carboplatin Injection, EBEWE Pharma, Approval
  • Inderal (propranolol hydrochloride) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
  • Inspra (eplerenone) Tablets, Pfizer Global Pharmaceuticals, Labeling Revision
  • Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision
  • Mepron (atovaquone) Suspension, GlaxoSmithKline, Labeling Revision
  • Nevanac (nepafenac) Ophthalmic Suspension, Alcon, Labeling Revision
  • Strattera (atomoxetine hydrochloride) Capsules, Eli Lilly and Co., New or Modified Indication
  • Uroxatral (alfuzosin hydrochloride) Extended Release Tablets, Sanofi-Aventis US, LLC, Labeling Revision

May 9, 2008

• BPCA/Pediatric Exclusivity Statistics:
  • Pediatric Exclusivity Statistics (updated)
  • Written Requests Issued (updated)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• Office of Generic Drugs: April First-Time Generic Drug Approvals

May 8, 2008

• Letters
  • Notice of Violation Letter: Fosrenol (lanthanum carbonate)
  • Warning Letter: Trileptal (oxcarbazepine)
• Paragraph IV Patent Certifications (updated 5/7/2008)

May 7, 2008

• Drugs@FDA Downloadable Data Files (updated)
• New and Generic Drug Approvals
  • Advair Diskus 100/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, New Dosage Regimen
  • Advair Diskus 250/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, New Dosage Regimen
  • Advair Diskus 500/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, New Dosage Regimen
  • Argatroban Injection, Encysive Pharmaceuticals, Inc., Efficacy Supplement with Clinical Data to Support
  • Brevital Sodium (methohexital sodium) Injection, JHP Pharmaceuticals, LLC, Labeling Revision
  • Bumetanide Injection, Baxter Healthcare Corp., Approval
  • Cardiolite (Technetium Tc99m Sestamibi Kit) Injection, Bristol Myers Squibb, Patient Population Altered
  • Humalog Mix 50/50 (insulin lispro protamine [rDNA origin] and insulin lispro [rDNA origin]) Injection, Eli Lilly and Co., Labeling Revision
  • Janumet (sitagliptin phosphate and metformin hydrochloride) Tablets, Merck & Co., Inc., Manufacturing Change or Addition
  • Levaquin (levofloxacin) Tablets, Ortho-McNeil-Janssen Pharmaceutical, Inc., Patient Population Altered
  • Levaquin (levofloxacin) Injection, Ortho-McNeil-Janssen Pharmaceutical, Inc., Patient Population Altered
  • Levaquin in Dextrose 5% in Plastic Container (levofloxacin) Injection, Ortho-McNeil-Janssen Pharmaceutical, Inc., Patient Population Altered
  • Levaquin (levofloxacin) Oral Solution, Ortho-McNeil-Janssen Pharmaceutical, Inc., Patient Population Altered
  • Ropinirole Hydrochloride Tablets, Mylan Pharmaceuticals Inc., Approval
  • Ropinirole Hydrochloride Tablets, Teva Pharmaceuticals, Approval
  • Ropinirole Hydrochloride Tablets, Roxane Laboratories, Inc., Approval
  • Ropinirole Hydrochloride Tablets, Par Pharmaceutical, Inc., Approval
  • Sensipar (cinacalcet hydrochloride) Tablets, Amgen, Inc., Labeling Revision
  • Vancocin Hydrochloride in Plastic Container (vancomycin hydrochloride) Injection, Baxter Healthcare Corp., Labeling Revision

May 6, 2008

• CDER Manual of Policies and Procedures (MaPPs) 4520.2R Providing General Consumer Information on New Molecular Entities on CDER’s Web Site
• FDA/ISPE Co-sponsored Event: Regulatory Perspectives on Hot Topics, Regulatory Trends, and Observations (E07), June 4-5, Washington, DC. Meeting information and registration
• New and Generic Drug Approvals
  • Azelastine Hydrochloride Nasal Spray, Apotex Inc., Tentative Approval
  • Gleevec (imatinib mesylate) Tablets, Novartis Pharmaceuticals, Package Change
  • Lexiva (fosamprenavir calcium) Tablets, GlaxoSmithKline, Labeling Revision
  • Lexiva (fosamprenavir calcium) Oral Suspension, GlaxoSmithKline, Labeling Revision
  • Pravastatin Sodium Tablets, Zydus Pharmaceuticals, Approval
  • Zolpidem Tartrate Tablets, Hikma Pharmaceuticals, Approval
• The Prescription Drug User Fee Act (PDUFA) Dear Colleague Letter, Attachment A   Attachment B
• Pubic Workshop: Developing Guidance on Conducting Scientifically Sound Pharmacoepidemiologic Safety Studies Using Large Electronic Healthcare Data Sets, Wednesday, May 7, 2008, Silver Spring, MD. Federal Register Notice

May 2, 2008

• Drug Safety Oversight Board Roster  (updated)
• Drug Safety Oversight Board Meeting, March 20, 2008 Public Summary
• Drug Shortage: Drug to be Discontinued: Tilade Inhaler (nedocromil sodium inhalation aerosol)
• BPCA/Pediatric Exclusivity Statistics: List of Determinations Including Written Request (updated)
• New and Generic Drug Approvals
  • Amitiza (lubiprostone) Capsules, Sucampo Pharma, New or Modified Indication 
  • Flomax (tamsulosin hydrochloride) Capsules, Boehringer Ingelheim Pharma, Labeling Revision
  • Imodium Advanced (loperamide hydrochloride and simethicone) Chewable Tablets, McNeil Consumer, Efficacy Supplement with Clinical Data to Support
  • Imodium Advanced (loperamide hydrochloride and simethicone) Tablets, McNeil Consumer, Efficacy Supplement with Clinical Data to Support
  • Losartan Potassium and Hydrochlorothiazide Tablets, Zydus Pharma, Tentative Approval
  • NuvaRing (etonogestrel and ethinyl estradiol) Vaginal Ring, Organon, Labeling Revision
  • Tenormin (atenolol) Tablets, AstraZeneca Pharma, Labeling Revision
  • Timolol Maleate Ophthalmic Solution, FDC Limited, Approval
• The prescribing information for Enbrel (etabercept) is revised to include a boxed warning about infections. MedWatch Safety Information.

May 1, 2008

• Guidance for Industry: Comprehensive List of Guidance Documents
• Guidance for Industry: New/Revised/Withdrawn List for 2008
• New and Generic Drug Approvals
  • Anastrozole Tablets, Zydus Pharma, Tentative Approval
  • Ciclopirox Topical Gel, Nycomed US, Inc., Tentative Approval
  • Ciprofloxacin Injection, Claris Lifesciences, Approval
  • Donepezil Hydrochloride Tablets, Teva Pharma, Approval
  • Escitalopram Oxalate Tablets, Zydus Pharma, Tentative Approval
  • Granisetron Hydrochloride Injection, Ebewe Parenta, Approval
  • Mepivacaine Hydrochloride Injection, Hospira Inc., Approval
  • Metoprolol Tartrate Injection, Hospira Inc., Approval
  • Omeprazole Delayed-Release Capsules, Lek Pharm, Tentative Approval
  • Optiray (Ioversol) Injection, Mallinckrodt, Labeling Revision
  • Penicillin V Potassium Tablets, Aurobindo Pharma, Approval
  • Sodium Chloride 0.9% in Plastic Container Injection, Mallinckrodt, Labeling Revision
  • Trandolapril Tablets, Mylan Pharma, Approval
• Pediatric Exclusivity Statistics: Pediatric Exclusivity Labeling Changes (updated)
• Prescription Drug User Fee Act (PDUFA) Billable Products  (updated)

April 30, 2008

• Common Technical Document (CTD) Modules/Sections Corresponding to Summary Data Tables in Bioequivalence Submissions to ANDAs (updated)
• Drugs@FDA Downloadable Data Files (updated)
• FDA approves Amitiza (lubiprostone) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over.
• Postmarketing Study Commitments (updated)

April 29, 2008

• Actavis Totowa LLC recalls all strengths of Digitek (digoxin tablets, USP), a drug used to treat heart failure and abnormal heart rhythms
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• New and Generic Drug Approvals
  • Efavirenz Tablets, Matrix Labs, Tentative Approval
  • Lamivudine and Zidovudine Tablets, Hetero Drugs, Tentative Approval
  • Optiray (Ioversol) Injection, Mallinckrodt, Labeling Revision
  • Thioridazine Hydrochloride Tablets, Mylan Pharma, Expiration Date Change
  • Zidovudine Tablets, Hetero Drugs, Approval

April 28, 2008

• Drug Master Files (updated)
• Drug Shortage: Resolved; Lymphazurin 1% injection (isosulfan blue)
• New and Generic Drug Approvals
  • Anastrazole Tablets, Watson Labs, Tentative Approval
  • Aplenzin (Bupropion Hydrobromide) Extended-release Tablets, Biovail Labs, Approval
  • Children's Cetirizine Hydrochloride Allergy Syrup, Ranbaxy Labs, Approval
  • Children's Cetirizine Hydrochloride Hives Relief Syrup, Ranbaxy Labs, Approval
  • Fiorinal with Codeine (butalbital, aspirin, caffeine and codeine phosphate) Capsules, Watson Labs, Labeling Revision
  • Maxitrol (neomycin sulfate, polymyxin B sulfate and dexamethasone) Ophthalmic Suspension, Falcon Pharma, Labeling Revision
  • Moxifloxacin Hydrochloride Tablets, Dr. Reddy’s Labs, Tentative Approval 
  • Nicotine Polacrilex Gum (2 mg), Perrigo R & D, Approval
  • Nicotine Polacrilex Gum (4 mg), Perrigo R & D, Approval
  • Phentermine Hydrochloride Capsules, KVK-Tech, Approval
  • Primidone Tablets, Amneal Pharma, Approval
  • Promethazine Hydrochloride Injection, Hikma Farmaceutica, Approval
  • Relistor (methylnaltrexone bromide) Subcutaneous Injection, Progenics Pharma, Approval
  • Singulair (montelukast sodium) Chewable Tablets, Merck & Co., Labeling Revision
  • Singulair (montelukast sodium) Tablets, Merck & Co., Labeling Revision
  • Singulair (montelukast sodium) Oral Granules, Merck & Co., Labeling Revision

April 25, 2008

• FDA approves Relistor (methylnaltrexone bromide) for opioid-induced constipation
• FDA updates information to healthcare facilities and healthcare professionals about heparin and heparin-containing medical products
• New and Generic Drug Approvals
  • Dipyridamole Tablets, Lannett, Approval
  • Epoprostenol Sodium Injection, Teva Parenteral, Approval
  • Ondansetron Injection, Akorn-Strides, Approval 
• Paragraph IV Patent Certifications (updated)
• Postmarketing Study Commitments: Introduction (updated)

April 24, 2008

• New and Generic Drug Approvals
  • Actonel (risedronate sodium) Tablets, Procter & Gamble, Labeling Revision
  • Actonel (risedronate sodium) Tablets, Procter & Gamble, New Dosage Regimen
  • Declomycin (demeclocycline hydrochloride) Tablets, Stiefel Labs, Labeling Revision
  • Vyvanse (lisdexamfetamine dimesylate) Capsule, New River Pharmacueticals, Patient Population Altered
• Office of Nonprescription Products: Rx to OTC Switch (updated)

April 23, 2008

• Drugs@FDA Downloadable Data Files (updated)
• New and Generic Drug Approvals
  • Aplenzin (bupropion hydrobromide) Extended-Release Tablets, Biovail Labs, Approval
  • Cabergoline Tablets, Cobalt Labs, Approval
  • Children's Cetirizine Hydrochloride Allergy Syrup, Taro Pharma, Approval
  • Children's Cetirizine Hydrochloride Hives Relief Syrup, Taro Pharma, Approval
  • Irinotecan Hydrochloride Injection, Sun Pharma, Approval
  • Prevacid (lansoprazole) Delayed-Release Oral Suspension, TAP Pharma, Labeling Revision
  • Prevacid (lansoprazole) Delayed-Release Capsules, TAP Pharma, Labeling Revision
  • Prevacid (lansoprazole) Delayed-Release Orally Disintegrating Tablets, TAP Pharma, Labeling Revision
  • Topiramate Tablets, Apotex, Tentative Approval

April 22, 2008

• FDA approves Cimzia (certolizumab pegol) to treat Crohn's disease
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• New and Generic Drug Approvals
  • Ciprofloxacin in Dextrose 5% in Plastic Container Injection, Hikma Farmaceutica, Approval
  • Enablex (darifenacin hydrobromide) Extended Release Tablets, Novartis Pharma, Labeling Revision
  • Hydrocodone Bitartrate and Acetaminophen Oral Solution, Pharmaceutical Assoc., Approval
  • Singulair (montelukast sodium) Tablets, Merck & Co., Labeling Revision
  • Singulair (montelukast sodium) Chewable Tablets, Merck & Co., Labeling Revision
  • Singulair (montelukast sodium) Oral Granules, Merck & Co., Labeling Revision
  • Tigan (trimethobenzamide hydrochloride) Intramuscular Injection, JHP Pharma, Labeling Revision
• Warning Letter: Peridex Zila Pharmaceuticals, Inc.

April 21, 2008

• CDER updates Information on Adverse Event Reports and Heparin
• FDA issues a map of Countries with Contaminated Heparin API
• FDA/DIA co-sponsored conference: Emerging Regulatory Issues in Genomic Medicine, May 21-23, Mexico City, Mexico. Meeting information and registration
• New and Generic Drug Approvals
  • AUGMENTIN ES-600 (amoxicillin, clavulanate potassium) Powder for Oral Suspension, GlaxoSmithKline, Labeling Revision
  • AUGMENTIN XR (amoxicillin, clavulanate potassium) Extended Release Tablets, GlaxoSmithKline, Labeling Revision
  • COPEGUS (ribavirin) Tablets, Roche, Labeling Revision
  • Crixivan (indinavir sulfate) Capsules, Merck & Co., Labeling Revision
  • Cyclobenzaprine Hydrochloride Tablets, Amneal Pharma, Approval
  • Felodipine Extended-release Tablets, Mylan Pharma, Approval
  • Metformin Hydrochloride Extended-Release Tablets, NeuroSci Inc., Approval
  • Oxacillin (oxacillin sodium) Injection, Baxter Healthcare, Labeling Revision
  • Synthroid (levothyroxine sodium) Tablets, Abbott Labs, Labeling Revision
  • Timentin in Plastic Container (ticarcillin disodium, clavulanate potassium) Injection, GlaxoSmithKline, Labeling Revision
  • Timentin (ticarcillin disodium, clavulanate potassium) Injection, GlaxoSmithKline, Labeling Revision
  • Zosyn (piperacillin sodium, tazobactam sodium) Injection, Wyeth Pharma, Labeling Revision
  • Zosyn in Plastic Container (piperacillin sodium, tazobactam sodium) Injection, Wyeth Pharma, Labeling Revision
• Warning Letter: Inspection; Changzhou SPL Company, Ltd.
• Warning Letter: Viagra

April 18, 2008

• Approved Drug Products with Therapeutic Equivalence Evaluations Orange Book
• New and Generic Drug Approvals
  • Colistimethate Injection, AAP Pharma, Approval
  • Crixivan (indinavir sulfate) Capsules, Merck & Co., Labeling Revision
  • Diclofenac Sodium Ophthalmic Solution, Akorn Inc., Approval
  • Estradiol and Norethindrone Acetate Tablets, Breckenridge Pharma, Approval
  • Levaquin (levofloxacin) Tablets, Ortho-McNeil Pharma, Labeling Revision
  • Levaquin (levofloxacin) Injection, Ortho-McNeil Pharma, Labeling Revision
  • Levaquin in Dextrose 5% in Plastic Container (levofloxacin) Injection, Ortho-McNeil Pharma, Labeling Revision
  • Levaquin (levofloxacin) Oral Solution, Ortho-McNeil Pharma, Labeling Revision
  • Lithium Carbonate Capsules, West-Ward Pharma, Approval
  • Patanase (olopatadine hydrochloride) Nasal Spray, Alcon Research, Approval
  • Pilopine HS (pilocarpine hydrochloride) Ophthalmic Gel, Alcon Research, Labeling Revision
  • Pipracil (piperacillin sodium) Injection, Wyeth Pharma, Labeling Revision
  • Raloxifene Hydrochloride Tablets, Teva Pharma, Tentative Approval
  • Rizatriptan Benzoate Tablets, Teva Pharma, Tentative Approval
  • Treximet (sumatriptan, naproxen sodium) Tablets, Pozen Inc., Approval
• Office of Generic Drugs: March First-Time Generic Drug Approvals

April 17, 2008

• Postmarketing Study Commitments: Introduction (updated)

April 16, 2008

• CDER issues "Review of Therapeutic Equivalence Generic Bupropion XL 300 mg and Wellbutrin XL 300 mg"
• Drugs@FDA Downloadable Data Files (updated)
• Inactive Ingredient Search for Approved Drug Products
• New and Generic Drug Approvals
  • Advicor (niacin lovastatin) Extended Release Tablets, Abbott Labs, Labeling Revision
  • Diprivan (propofol) Injection, APP Pharma, Labeling Revision
  • Nallpen in Plastic Container (nafcillin sodium) Injection, Baxter Healthcare, Labeling Revision
  • Ofloxacin Ophthalmic Solution, Akorn Inc., Approval 
  • TriCor (fenofibrate) Tablets, Abbott Labs, Labeling Revision

April 15, 2008

• New and Generic Drug Approvals
  • Cleocin Phosphate (clindamycin phosphate) Injection, Pfizer, Labeling Revision
  • Cleocin Phosphate in Dextrose 5% in Plastic Container (clindamycin phosphate) I.V. Sterile Solution, Pfizer, Labeling Revision
  • Evamist (estradiol) Transdermal Spray, KV Pharma, Labeling Revision
  • Luvox (fluvoxamine maleate) Tablets, Jazz Pharma, Approval
  • PULMICORT FLEXHALER (budesonide) Inhalation Powder, AstraZeneca, Labeling Revision
  • Trelstar Depot (triptorelin pamoate) Injectable; Intramuscular, Watson Labs, Control Supplement
  • Trelstar LA (triptorelin pamoate) Injectable; Intramuscular, Watson Labs, Control Supplement
  • Unasyn (ampicillin sodium, sulbactam sodium) Injection, Pfizer, Labeling Revision
  • Zerit (stavudine) Capsules, Bristol-Myers Squibb, Labeling Revision
  • Zerit (stavudine) For Oral Solution, Bristol-Myers Squibb, Control Supplement
  • Zerit (stavudine) For Oral Solution, Bristol-Myers Squibb, Labeling Revision
• Paragraph IV Patent Certifications (updated)

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Date updated: May 16, 2008

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