Warning Letters 2010

By Effective Medicine  On  In Drugs Tagged ,  


2010 Warning Letters and Untitled Letters to Pharmaceutical Companies     
 

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 links in each month to view the letters in Adobe Acrobat format. [more…]

October 2010

September 2010

August 2010

July 2010

 

June 2010

May 2010

 

April 2010

Product/IssueCompany/IndividualDivisionReleasedPosted

BLA # 103705
Rituxan® (Rituximab) Injection for Intravenous Use

  • DDMAC Letter (PDF – 52KB)
  • Promotional Material (PDF – 2120KB)

Genentech, Inc.Division of Drug Marketing, Advertising and Communications4/29/105/5/10

NDA 022000
LIALDA®(mesalamine) Delayed Release Tablets

  • DDMAC Letter (PDF – 119KB)
  • Promotional Material (PDF – 742KB)

Shire Development, Inc.Division of Drug Marketing, Advertising and Communications4/27/105/5/10

NDA #020049
PENTASA® (mesalamine) Controlled-Release Capsules

  • DDMAC Letter (PDF – 48KB)
  • Promotional Material (PDF – 849KB)

Shire Development, Inc.Division of Drug Marketing, Advertising and Communications4/27/105/5/10

Institutional Review Board

  • Warning Letter

Ephraim McDowell Regional Medical CenterDivision of Scientific Investigations4/26/104/30/10

Institutional Review Board

  • Warning Letter

Brookwood Medical CenterDivision of Scientific Investigations4/22/104/30/10

NDA 021588
Gleevec® (imatinib mesylate)

  • Warning Letter
  • Promotional Material (PDF – 14MB)

Novartis OncologyDivision of Drug Marketing, Advertising and Communications4/21/105/4/10

NDA 021775
ENTEREG® (alvimopan) Capsules

  • DDMAC Letter [PDF-57KB]

Adolor CorporationDivision of Drug Marketing, Advertising and Communications4/21/104/23/10

NDA 021731
Eligard 45mg (leuprolide acetate for injectable suspension)

  • DDMAC Letter [PDF-62KB]
  • Promotional Material [PDF-2040KB]

Sanofi-Aventis U.S., Inc.Division of Drug Marketing, Advertising and Communications4/20/104/23/10

NDA 22-055
Altabax® (retapamulin ointment), 1%

  • Warning Letter
  • Promotional Material (PDF – 799KB)

GlaxoSmithKlineDivision of Drug Marketing, Advertising and Communications4/19/104/30/10

BLA #125326
Arzerra™ (ofatumumab) Injection, for intravenous infusion

  • DDMAC Letter [PDF-24KB]
  • Promotional Material [PDF-121KB]

GlaxoSmithKline 4/15/104/16/10

NDA # 022122
Voltaren® Gel (diclofenac sodium topical gel)

  • DDMAC Letter [PDF-50KB]
  • Promotional Material [PDF-631KB]

Novartis Consumer Health, Inc.Division of Drug Marketing, Advertising and Communications4/14/104/16/10

H1N1 Flu Virus-Related Products

  • Warning Letter

Super Body CareOffice of Compliance4/13/104/23/10

H1N1 Flu Virus Related Products

  • Warning Letter

Shreeji Homeo ClinicOffice of Compliance4/13/104/27/10

NDA #21-518
VESIcare® (solifenacin succinate) Tablets

  • DDMAC Letter [PDF-95KB]
  • Promotional Material [PDF-200KB]

Astellas Pharma US, Inc.Division of Drug Marketing, Advertising and Communications4/12/104/16/10

Unapproved/ Unauthorized Products Related to the H1N1 Flu Virus

  • Warning Letter

e-holistic health (Hannah Cooper)Office of Compliance4/12/104/23/10

NDA #021135
Venofer® (iron sucrose injection, USP)

  • DDMAC Letter [PDF-158KB]
  • Promotional Material [PDF-479KB]

Luitpold Pharmaceuticals, Inc.Division of Drug Marketing, Advertising and Communications4/12/104/16/10

Sponsor Investigation

  • Warning Letter

Pfizer, Inc.Division of Scientific Investigations4/9/104/23/10

NDA #010104
MEPHYTON® (PHYTONADIONE) Vitamin K1

  • DDMAC Letter [PDF-104KB]
  • Promotional Materials [PDF-289KB]

Aton Pharma, Inc.Division of Drug Marketing, Advertising and Communications4/6/104/7/10

False/misleading claims related to LipoDissolve products

  • Warning Letter

Pure med spaOffice of Compliance4/6/104/7/10

NDA #s 20-628, 21-785 Invirase® (saquinavir mesylate) Capsules and Tablets

  • DDMAC Letter [PDF-104KB]
  • Promotional Material [PDF-3174KB]

Hoffman-La Roche IncDivision of Drug Marketing, Advertising and Communications4/6/104/23/10

False/misleading claims related to LipoDissolve products

  • Warning Letter

All about you medispaOffice of Compliance4/5/104/7/10

False/misleading claims related to LipoDissolve products

  • Warning Letter

IdinhealthOffice of Compliance4/5/104/7/10

False/misleading claims related to LipoDissolve products

  • Warning Letter

Monarch medispaOffice of Compliance4/5/104/7/10

False/misleading claims related to LipoDissolve products

  • Warning Letter

Spa 35Office of Compliance4/5/104/7/10

False/misleading claims related to LipoDissolve products

  • Warning Letter

Medical CosmeticOffice of Compliance4/5/104/7/10

Clinical Investigation

  • Warning Letter

Robert Deitz, M.D.Division of Scientific Investigations4/1/104/23/10

March 2010
February 2010

 

January 2010

FDA FOI Page.

The letters are arranged in chronological order by month.  Click on the product name to view the letters in Adobe Acrobat (PDF) format. 

    





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