Warning Letters and Untitled Letters to Pharmaceutical Companies 2009

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FDA/Center for Drug Evaluation and Research

Warning Letters and Untitled Letters
to Pharmaceutical Companies
2009

These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office. This page only covers Division of Drug Marketing and Communications and Headquarters Warning Letters. For District Office Warning Letters see the Main FDA FOI Warning Letters Page. Some of the letters have been redacted or edited to remove confidential information. Click on the month to view the letters in Adobe Acrobat format. [more...]

Product/Issue	Company/Individual	Division/Office	Released	Posted
2009 [2008] [2007] [2006] [2005] [2004] [2003] [2002] [2001] [2000] [1999] [1998] [1997]
April 2009
Investigational Review Board (Warning Letter)	Coast IRB	Division of Scientific Investigations	4/14/2009	4/14/2009
Site Inspection (Warning Letter)	Qingdao Jiulong Biopharmaceuticals Co. Ltd.	Division of Manufacturing and Product Quality	4/14/2009	4/16/2009
Site Inspection (Warning Letter)	Shanghai No. 1 Biochemical & Pharmaceutical Co. Ltd.	Division of Manufacturing and Product Quality	4/14/2009	4/16/2009
BLA 125104 Tysabri (natalizumab) injection for intravenous use FDA/DDMAC letter Promotional Material	Biogen Idec	Division of Drug Marketing, Advertising, and Communications	4/2/2009	4/3/2009
NDA 20-839 Plavix (clopidogrel bisulfate) Tablets FDA/DDMAC letter Promotional Material	Sanofi Aventis, U.S.	Division of Drug Marketing, Advertising, and Communications	4/2/2009	4/3/2009
NDA 21-071 Avandia (rosiglitazone maleate) Tablets; NDA 21-410 Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets; NDA 21-700 Avandaryl (rosiglitazone maleate and glimepiride) Tablets; NDA 21-319 Avodart (dutasteride) Soft Gelatin Tablets; NDA 22-012 Coreg CR (carvedilol phosphate) Extended-release Capsules; NDA 22-059 Tykerb (lapatinib) Tablets FDA/DDMAC letter Promotional Material	GlaxoSmithKline	Division of Drug Marketing, Advertising, and Communications	4/2/2009	4/3/2009
NDA 21-742 BYSTOLIC (nebivolol) Tablets; NDA 21-431 CAMPRAL (acamprosate calcium) Delayed-Release Tablets; NDA 21-323, 21-365, 21-440 Lexapro (escitalopram) Tablets/ Oral Solution; NDA 21-487, 21-627 Namenda (memantine) Tablets/Oral Solution FDA/DDMAC letter Promotional Material	Forest Laboratories, Inc.	Division of Drug Marketing, Advertising, and Communications	4/2/2009	4/3/2009
NDA 21-947 FENTORA (fentanyl buccal tablet); NDA #22-249 TREANDA (bendamustine hydrochloride) for Injection, for intravenous infusion FDA/DDMAC letter Promotional Material	Cephalon, Inc.	Division of Drug Marketing, Advertising, and Communications	4/2/2009	4/3/2009
NDA 21-400 LEVITRA (vardenafil HCl) Tablets; NDA 21-676, 21-873, 22-045 YAZ (drospirenone and ethinyl estradiol) Tablets; NDA 21-225 Mirena (levonorgestrel-releasing intrauterine system) FDA/DDMAC letter Promotional Material	Bayer Healthcare Pharmaceuticals, Inc.	Division of Drug Marketing, Advertising, and Communications	4/2/2009	4/3/2009
NDA 21-976 PREZISTA (darunavir) Tablet FDA/DDMAC letter Promotional Material	Johnson & Johnson Pharmaceutical Services	Division of Drug Marketing, Advertising, and Communications	4/2/2009	4/3/2009
NDA 20-753 AROMASIN (exemestane) tablets; NDA 21-540 CADUET (amlodipine besylate/atorvastatin calcium) Tablets; NDA 21-928 CHANTIX® (varenicline) Tablets; NDA 21-228 Detrol LA (tolterodine tartrate) extended release capsules; NDA 21-446, 21-723, 21-724 LYRICA (pregabalin) Capsules; NDA 20-998, 21-156 CELEBREX (celecoxib) capsules FDA/DDMAC letter Promotional Material	Pfizer, Inc.	Division of Drug Marketing, Advertising, and Communications	4/2/2009	4/3/2009
NDA 20-726 Femara (letrozole tablets); NDA 21-283 Diovan (valsartan) Tablets; NDA 21-990 Exforge (amlodipine and valsartan) Tablets; NDA 21-882 EXJADE (deferasirox) Tablets for Oral Suspension; NDA 21-588 GLEEVEC (imatinib mesylate) Tablets for Oral Use FDA/DDMAC letter Promotional Material	Novartis Pharmaceuticals Corp.	Division of Drug Marketing, Advertising, and Communications	4/2/2009	4/3/2009
BLA 125085 Avastin (Bevacizumab); BLA 125156 LUCENTIS (ranibizumab injection); BLA 103705, 103737 RITUXAN (rituximab); BLA 103976 Xolair (Omalizumab) For Subcutaneous Use; BLA 103792 HERCEPTIN (trastuzumab); BLA 103532 Pulmozyme (dornase alfa) Inhalation Solution FDA/DDMAC letter Promotional Material	Genentech, Inc.	Division of Drug Marketing, Advertising, and Communications	4/2/2009	4/3/2009
NDA 21-395 Spiriva HandiHaler (tiotropium bromide inhalation powder); NDA 20-579 Flomax (tamsulosin hydrochloride) Capsules; NDA 20-667 Mirapex (pramipexole dihydrochloride) Tablets FDA/DDMAC letter Promotional Material	Boehringer Ingelheim Pharmaceuticals, Inc.	Division of Drug Marketing, Advertising, and Communications	4/2/2009	4/3/2009
NDA 21-995 JANUVIA (sitagliptin) Tablets; NDA 20-788 PROPECIA (finasteride) Tablets; NDA 20-829, 20-830, 21-409 SINGULAIR (montelukast sodium) granule; tablet, chewable; tablet, film coated; NDA 21-549 EMEND (aprepitant) Capsules FDA/DDMAC letter Promotional Material	Merck & Co., Inc.	Division of Drug Marketing, Advertising, and Communications	4/2/2009	4/3/2009
NDA 21-455, 21-858 BONIVA (ibandronate sodium) Tablets; BLA 103964 PEGASYS (peginterferon alfa-2a) for Injection; NDA 20-896 XELODA (capecitabine) Tablets FDA/DDMAC letter Promotional Material	Hoffman-LaRoche, Inc.	Division of Drug Marketing, Advertising, and Communications	4/2/2009	4/3/2009
NDA 21-427, 21-733, 22-148 Cymbalta (duloxetine hydrochloride) Delayed- Release Capsules for Oral Use; NDA 20-815, 22-042 EVISTA (raloxifene hydrochloride) Tablets for Oral Use; NDA 20-509 Gemzar (gemcitabine HCl) for Injection FDA/DDMAC letter Promotional Material	Eli Lilly and Co.	Division of Drug Marketing, Advertising, and Communications	4/2/2009	4/3/2009
March 2009
Product/Issue	Company/Individual	Division/Office	Released	Posted
Clinical Investigation (Warning Letter)	Ronald Bukowski, M.D.	Division of Scientific Investigations	3/30/2009	4/21/2009
Morphine Sulfate Tablets, 15 mg & 30 mg; Morphine Sulfate Solution Immediate Release Concentrate, 20 mg/ml; Morphine Sulfate Solution Immediate Release Oral Solution, 20mg/5ml Warning letter [HTML] [PDF]	Glenmark Generics Inc.	Office of Compliance	3/30/2009	3/31/2009
Morphine Sulfate Solution Immediate Release Concentrate, 20 mg/ml; Hydromorphone HCI Tablets, 2mg and 4mg Warning letter [HTML] [PDF]	Lannett Company, Inc.	Office of Compliance	3/30/2009	3/31/2009
Morphine Sulfate Tablets, 15 mg & 30 mg; Morphine Sulfate Solution Concentrate, 20 mg/ml Warning letter [HTML] [PDF]	Lehigh Valley Technologies Inc.	Office of Compliance	3/30/2009	3/31/2009
Morphine Sulfate Concentrate Oral Solution 20mg/ml Warning letter [HTML] [PDF]	Mallinckrodt Inc. Pharmaceuticals Group	Office of Compliance	3/30/2009	3/31/2009
Roxanol Oral Solution, 20 mg/ml; Roxicodone Tablets, 5 mg Warning letter [HTML] [PDF]	Xanodyne Pharmaceuticals Inc.	Office of Compliance	3/30/2009	3/31/2009
Morphine Sulfate Immediate Release Tablets, 30 mg; Hydromorphone Tablets, 2 mg; Hydromorphone Hydrochloride Tablets 4 mg Warning letter [HTML] [PDF]	Physicians Total Care, Inc.	Office of Compliance	3/30/2009	3/31/2009
Hydromorphone Hydrochloride Tablets, 2 mg & 4 mg Warning letter [HTML] [PDF]	Roxane Laboratories, Inc.	Office of Compliance	3/30/2009	3/31/2009
Roxanol Oral Solution, 20 mg/ml; Roxicodone Tablets, 5 mg Warning letter [HTML] [PDF]	Boehringer Ingelheim Roxane Inc.	Office of Compliance	3/30/2009	3/31/2009
Morphine Sulfate Solution Immediate Release 20mg/ml Warning letter [HTML] [PDF]	Cody Laboratories, Inc.	Office of Compliance	3/30/2009	3/31/2009
Treximet (sumatriptan and naproxen sodium) Tablets FDA/DDMAC letter Promotional material	GlaxoSmithKline	Division of Drug Marketing, Advertising, and Communications	3/9/2009	4/7/2009
Clinical Investigation (Warning Letter)	Charles J. Cote, M.D.	Division of Scientific Investigations	3/2/2009	3/3/2009
Clinical Investigation (Warning Letter)	Virendra Desai, M.D.	Division of Scientific Investigations	3/2/2009	3/5/2009
Clinical Investigation (Warning Letter)	Manuel J. Quinones, M.D.	Division of Scientific Investigations	3/3/2009	3/5/2009
February 2009
Product/Issue	Company/Individual	Division	Released	Posted
Avodart (dutasteride) Soft Gelatin Capsules promotional material	GlaxoSmithKline	Division of Drug Marketing, Advertising, and Communications	2/18/2009	2/26/2009
Inspection of Pharmaceutical Manufacturing Facility (Warning Letter)	Barrie Levitt, M. D.	Division of Manufacturing & Product Quality	2/5/2009	2/5/2009
Letairis (ambrisentan)	Gilead Sciences, Inc.	Division of Drug Marketing, Advertising, and Communications	2/27/2009	3/5/2009
January 2009
Product/Issue	Company/Individual	Division	Released	Posted
Clinical Investigation (Warning Letter)	Nicola Spirtos, M.D.	Division of Scientific Investigations	1/3/2009	1/22/2009
Depakote (divalproex sodium) promotional material	Abbott Laboratories	Division of Drug Marketing, Advertising, and Communications	1/22/2009	1/29/2009
Sanctura (trospium chloride) promotional material	Indevus Pharmaceuticals, Inc.	Division of Drug Marketing, Advertising, and Communications	1/27/2009	1/29/2009

Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter. If you wish to obtain available additional information on the current status of an issue in a particular warning letter or notice of violation on this website, please contact the Agency or the recipient of the letter directly. Inquiries to FDA should be sent to:

Food and Drug Administration
Freedom of Information Staff (HFI-35)
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The letters are arranged in chronological order by month. Click on the product name to view the letters in Adobe Acrobat (PDF) format. Go here for further information about Adobe Acrobat and download instructions.

Also see the "Cyber" Letters.

Last updated: April 16, 2009