... , Photocure, ASA, Efficacy Supplement with Clinical Data to Support Sarafem (fluoxetine hydrochloride) Capsules, Eli Lilly and Co, Labeling Revision Xyzal (levocetirizine dihydrochloride) Oral Solution, UCB, Inc, Labeling Revision Zidovudine Syrup, Cipla, Ltd, Approval June 27, 2008 Guidance for Industry: Individual Product Bioequivalence Recommendations [] has been revised with Finalized recommendations. CDER Organization Charts [] [PDF] (updated) List of Authorized Generic Drugs June 26, 2008 New and Generic Drug Approvals Advil Cold & Sinus (ibuprofen and pseudoephedrine hydrochloride) Capsules, Wyeth Consumer Healthcare, Labeling Revision Aptivus (tipranavir) Capsules, Boehringer Ingelheim Pharmaceuticals, Inc, New or Modified Indication Aptivus (tipranavir) Oral Solution, Boehringer Ingelheim Pharmaceuticals, Inc, Approval Aptivus (tipranavir) Oral Solution, Boehringer Ingelheim Pharmaceuticals, Inc, Approval Azithromycin Oral Suspension, Teva Pharmaceuticals USA, Approval Celestone Soluspan (betamethasone acetate and betamethasone sodium phosphate) Injection, Schering Corp, Labeling Revision Durezol (difluprednate) Ophthalmic Emulsion, Sirion Therapeutics, Inc, Approval Famotidine Injection, Akorn-Strides, ...

... , Labeling Revision Zestril (lisinopril) Tablets, AstraZeneca Pharmaceuticals LP, Labeling Revision Zoledronic Acid Injection, PharmaForce, Inc, Tentative Approval May 26, 2009 Drug Shortages: Current Drug Shortage: Technetium Tc99m Generators (updated) FDA updates information for stockpiled antivirals at or nearing expiration. H1N1 Flu Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion May 22, 2009 List of Determinations Including Written Request (updated) Drug Shortages: Current Drug Shortage: Technetium Tc99m Generators New and Generic Drug Approvals Advil (ibuprofen) Tablets, Wyeth Consumer Healthcare, Labeling Revision Advil Allergy Sinus (clorpheniramine maleate, ibuprofen and pseudoephedrine hydrochloride) Tablets, Wyeth Consumer Healthcare, Labeling Revision Advil Cold & Sinus (ibuprofen and pseudoephedrine hydrochloride) Capsules, Wyeth Consumer Healthcare, Labeling Revision Advil Liqui-gels (ibuprofen) Capsules, Wyeth Consumer Healthcare, Labeling Revision Calcium Disodium Versenate (edetate calcium disodium) Injection, Graceway Pharmaceuticals, LLC, Labeling Revision Children ' s Advil (ibuprofen) Oral Suspension, Wyeth Consumer Healthcare, Labeling Revision Children ' s Advil Cold (ibuprofen ...

... death if azathioprine, an immunosuppressant, and mercaptopurine, an antimetabolite, are given together. http :// www.accessdata.fda.gov / psn / transcript.cfm? show = 57 #5 Vaccine Mix-ups: Adacel (Tdap) and Daptacel (DTaP) ISMP recently reported on several mix-ups between DAPTACEL, which is diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP ), and ADACEL, which is tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (Tdap). http :// www.accessdata.fda.gov / psn / transcript.cfm? show = 57 #6 Ibuprofen Can Interfere with Aspirin's Antiplatelet Effect FDA is alerting healthcare professionals that taking 400 mg of ibuprofen can interfere with the antiplatelet effect of low dose aspirin. http :// www.accessdata.fda.gov / psn / transcript.cfm? show = 57 #7 ...

... Sabril is the first drug in the United States approved to treat the disorder, characterized by a severe type of seizure that usually appears in the first year of life, typically between ages 4 months and 8 months. The disorder can be debilitating because of the frequency of difficult-to-control daily seizures. Sabril (vigabatrin) Tablets have been approved for adult use in combination with other medications to treat complex partial seizures that have not responded adequately to previous drug therapies. August 20, 2009_FDA Issues Warning Letters to Marketers of Topical Ibuprofen Drug Products The U.S. Food and Drug Administration today announced that the agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen. The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, are unapproved new drugs that require an approved new drug application in order to be legally marketed. Under its OTC drug monograph system, the FDA allows some OTC drugs to be marketed without first obtaining agency approval. These drugs must ...

... . June 12, 2009_FDA Requests Labeling Change for Leukotriene Modifiers The U.S. Food and Drug Administration today provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. The FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair ), zafirlukast (Accolate ), and zileuton (Zyflo and Zyflo CR). June 11, 2009_FDA Approves Injectable Form of Ibuprofen The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever. “ Injectable ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) are promising pain management options ,” said Bob Rappaport, M.D, director, Division of Anesthesia, Analgesia and Rheumatology Drug Products in the FDA ’ s Center for Drug Evaluation and Research. “ But until now there were only oral forms of most NSAIDs. An injectable ibuprofen product can provide patients with relief from pain and ...

... Betterchem Health Drug Information DMFs Portal 21CFR Search Site Map CDER News Archive [index page] November 30, 2007 Best Pharmaceuticals for Children Act of 2007: List of Determinations including Written Request New and Generic Drug Approvals Escitalopram Oxalate Tablets, Caraco Pharma, Tentative Approval Haloperidol Tablets, Zydus Pharma, Approval Lamivudine and Zidovudine Tablets, Matrix Labs, Tentative Approval Mometasone Furoate Topical Solution, Altana Inc, Approval Olopatadine Hydrochloride Ophthalmic Solution, Apotex, Tentative Approval Oxycodone Hydrochloride and Ibuprofen Tablets, Barr Labs, Approval Office of Nonprescription Products: Rulemaking History for Nonprescription Products (updated) November 29, 2007 Rulemaking History for Nonprescription Products (updated) November 28, 2007 Adolescent Over-the-Counter (OTC) Drug Product Use: A Public Workshop [PDF] Drugs @FDA Downloadable Data Files (updated) New and Generic Drug Approvals Ciprofloxacin Extended-release Tablets, Anchen Pharma, Approval FOSCAVIR (foscarnet sodium) Injection, AstraZeneca, Labeling Revision Oxycodone and Acetaminophen Tablets, Interpharm Inc, Approval Oxycodone Hydrochloride and Ibuprofen Tablets, Watson Labs, Approval Zocor (simvastatin) Tablets, Merck & Co ...

... and Generic Drug Approvals Cilostazol Tablets, Mylan Pharma, Approval Fluoxetine Capsules, Teva Pharma, Tentative Approval HYZAAR (losartan potassium hydrochlorothiazide) Tablets, Merck Research, Labeling Revision Levofloxacin Tablets, Zydus Pharma, Tentative Approval Pantoprazole Sodium Delayed-Release Tablets, Teva Pharma, Tentative Approval Pantoprazole Sodium Delayed-Release Tablets, Sandoz Inc, Tentative Approval Simvastatin Tablets, Aurobindo Pharma, Tentative Approval Zonisamide Capsules, Watson Labs, Approval April 20, 2006 Drug Approval Reports: Fast Track Reports Approvals Statistics (Fiscal Year) New and Generic Drug Approvals Advil (ibuprofen) tablets / capsules, Wyeth Consumer, Labeling Revision 018989 Advil Cold & Sinus (ibuprofen & pseudoephedrine HCl) tablets, Wyeth Consumer, Labeling Revision Advil Cold & Sinus Liquigels (ibuprofen / pseudoephedrine HCl capsules ), Wyeth Consumer, Labeling Revision Alphagan P (brimonidine tartrate ophthalmic solution ), Allergan, Labeling Revision Avandamet (rosiglitazone maleate / metformin Hcl ), GlaxoSmithKline, Labeling Revision Cyclobenzaprine Hydrochloride Tablets, Jubilant Pharma, Approval Namenda (memantine hydrochloride) Tablets, Forest Labs, Labeling Revision Namenda (memantine hydrochloride) Oral Solution, Forest Labs, ...

... breakage of Protonix I.V. during attempts to connect vials to spiked intravenous system adaptors. MedWatch Safety Info. September 23, 2004 New and Generic Drug Approvals Aromasin (exemestane tablets ), Pfizer Inc, Labeling Revision CANASA (mesalamine) Suppository, Axcan Scandipharm, Labeling Revision Ciprofloxacin Injection, Bedford Labs, Tentative Approval Diuril (chlorothiazide) Tablets Merck & Co, Inc, Labeling Revision Diuril (chlorothiazide) Intravenous Injection Merck & Co, Inc, Labeling Revision Diuril (chlorothiazide) Oral Suspension Merck & Co, Inc, Labeling Revision Ibuprofen Oral Suspension, Perrigo R & D, Approval 2009 Betterchem.com ...

... Betterchem Health Drug Information DMFs Portal 21CFR Search Site Map CDER News Archive [index page] October 12, 2004 New and Generic Drug Approvals Betamethasone Dipropionate Ointment, Taro Pharma, Approval Fenoldopam Mesylate Injection, Bedford Labs, Approval Flumazenil Injection, American Pharma, Approval Flumazenil Injection, Baxter HealthCare, Approval Flumazenil Injection, Bedford Labs, Approval Flumazenil Injection, Apotex Corp, Approval Flumazenil Injection, Sicor Pharma, Approval Fosinopril Sodium Tablets, Sandoz Inc, Approval Hydrocodone Bitartrate and Ibuprofen Tablets, Interpharm, Supplement NovoLog (insulin aspart [rDNA origin] injection ), Novo Nordisk, Labeling Revision NovoLog Mix 70 / 30, Novo Nordisk, Labeling Revision VANTAS (histrelin implant ), Valera Pharma, Approval October 8, 2004 Biogen Idec and Genentech notify healthcare professionals of revisions to the prescribing section of the Rituxan (rituximab) label due to reports of Hepatitis B virus (HBV) reactivation with fulminant hepatitis, hepatic failure, and death in some patients with hematologic malignancies. MedWatch Safety Info. Drug Master Files (updated) FDA approves first-time generic Gabapentin for adjunctive therapy in ...

... [] or [PDF] Drugs @FDA Downloadable Data Files FDA strengthens the labels of two specific types of antibiotics to ensure their proper use. FDA Talk Paper New and Generic Drug Approvals Antara (Fenofibrate) Capsules, Reliant Pharma, Approval BEXTRA (valdecoxib) Tablets, Pfizer, Labeling Revision Cilostazol Tablets, Amide Pharma, Approval Cilostazol Tablets, Teva Pharma, Approval Cosmegen (Dactinomycin) Injection, Merck & Co, Labeling Revision Clindesse (clindamycin phosphate) Vaginal Cream, KV Pharma, Approval Combunox (Oxycodone HCl and Ibuprofen) Tablets, Forest Laboratories, Approval Desmopressin Acetate Nasal Solution, Apotex Inc, Tentative Approval Diovan (valsartan) Tablets, Novartis Pharma, Labeling Revision Levaquin (Levofloxacin) Tablets, Ortho-McNeil, New or Modified Indication Levaquin (Levofloxacin) Injection, Ortho-McNeil, New or Modified Indication Levaquin (Levofloxacin) Oral Solution, Ortho-McNeil, New or Modified Indication Lexiva (Fosamprenavir calcium) tablets, GlaxoSmithKline, Labeling Revision Malarone (atovaquone and proguanil hydrochloride) Tablets, GlaxoSmithKline, Labeling Revision Meridia (Sibutramine HCL Monohydrate) Capsules, Abbott, Labeling ...