Selected Enforcement Actions on Unapproved Drugs
 

• Injectable Colchicine Products
• Hydrocodone Drug Products
• Timed-Release Drug Products Containing Guaifenesin
• PharmaFab Inc.
• Trimethobenzamide Hydrochloride Suppositories
• Ergotamine-Containing Drug Products
• Quinine Sulfate Drug Products
• Vita-Erb, Ltd.
• C. R. Canfield Co., Inc.
• Actavis Totowa, LLC
• Syntho Pharmaceuticals, Inc. and Intermax Pharmaceuticals, Inc.
• Sheffield Laboratories, Division of Faria Limited LLC
• Concord Laboratories, Inc.
• Carbinoxamine Drug Products
• Neil Laboratories, Inc.
• Scientific Laboratories, Inc.
• Pharmakon Laboratory, Inc.
• Propharma, Inc.
• Lane Labs-USA, Inc.
• Exocrine Pancreatic Insufficiency Drug Products
• Carolina Pharmaceuticals, Inc.
• Forest Laboratories, Inc.
• Single Ingredient Extended Release Guaifenesin Drug Products
• Digoxin Products for Oral Use
• Sage Pharmaceuticals, Inc.
• Levothyroxine Sodium Drug Products

Injectable Colchicine Products

• FDA News: FDA Takes Action to Stop the Marketing of Unapproved Injectable Drugs Containing Colchicine (Issued February 6, 2008)
• Questions and Answers About FDA's Enforcement Action Against Unapproved Injectable Colchicine Products
• Federal Register Notice [PDF] (February 6, 2008)

Hydrocodone Drug Products

• FDA News: FDA Takes Action to Stop Marketing of Unapproved Hydrocodone Products (Issued September 28, 2007)
• Questions and Answers About FDA’s Enforcement Action Regarding Unapproved Hydrocodone Drug Products
• Federal Register Notice [HTML] [PDF] (September 28, 2007)

Timed-Release Drug Products Containing Guaifenesin

• FDA News: FDA Takes Action to Stop Marketing of Unapproved Timed-Release Guaifenesin Drug Products (Issued May 25, 2007)
• Questions and Answers About FDA’s Enforcement Action Against Timed-Release Drug Products Containing Guaifenesin (updated 5/22/2008)
• Federal Register Notice [HTML] [PDF] (May 29, 2007). FDA announced its intention to take enforcement action against unapproved drug products in timed-release dosage forms containing guaifenesin and persons who cause the manufacture or interstate shipment of such products.

PharmaFab Inc.

• FDA News: Manufacturer of Unapproved and Adulterated Drugs Agrees to Stop Illegal Practices (Issued April 25, 2007)
• Consent Decree of Permanent Injunction (April 24, 2007)
• FDA Complaint for Permanent Injunction (April 20, 2007)
• Warning Letter (Issued June 15, 2004)
• Warning Letter (Issued October 11, 2002)

Trimethobenzamide Hydrochloride Suppositories

• FDA News: FDA Announces that Companies Must Stop Marketing Suppository Products Containing Trimethobenzamide (Issued April 6, 2007)
• Federal Register Notice [HTML] [PDF]

Ergotamine-Containing Drug Products

• FDA News: FDA Takes Action to Halt Marketing of Unapproved Ergotamine Companies Ordered to Cease Manufacturing and Distribution of Illegal Drugs to Treat Migraine Headaches (Issued March 1, 2007)
• Warning Letters (Issued February 26, 2007)

Quinine Sulfate Drug Products

• FDA News: FDA Advances Effort Against Marketed Unapproved Drugs; Orders Unapproved Quinine Drugs from the Market
• Questions and Answers About FDA’s Enforcement Action Against Quinine Sulfate Drug Products (updated December 15, 2006)
• Federal Register Notice [HTML] [PDF] (December 15, 2006). FDA announced its intention to take enforcement action against unapproved drug products containing quinine (including quinine sulfate and any other salt of quinine) and persons who cause the manufacture of such products or their shipment in interstate commerce.

Vita-Erb, Ltd.

• Order of Permanent Injunction (Filed November 14, 2006)
• FDA Supplemental Complaint for Permanent Injunction (Filed June 9, 2006)
• Warning Letter (Issued April 29, 2004)
  

C. R. Canfield Co., Inc.

• FDA News: Permanent Injunction of Dental Products Manufacturer Furthers FDA Efforts Against Marketed Unapproved Drugs (Issued October 6, 2006)
• Consent Decree of Permanent Injunction (September 18, 2006)
• FDA Complaint for Permanent Injunction (September 15, 2006)
• Warning Letter (Issued September 24, 2004)

Actavis Totowa, LLC

• Warning Letter (Issued August 15, 2006)

Syntho Pharmaceuticals, Inc. and Intermax Pharmaceuticals, Inc.

• FDA News: FDA Continues To Tackle Unapproved Drugs (Issued October 5, 2006)
• Consent Decree of Permanent Injunction (August 10, 2006)
• FDA Complaint for Permanent Injunction (August 10, 2006)
• Warning Letter (Issued May 13, 2003)
• Warning Letter (Issued March 14, 2003)

Sheffield Laboratories, Division of Faria Limited LLC

• Warning Letter (Issued July 24, 2006)

Concord Laboratories, Inc.

• Warning Letter (Issued July 11, 2006)

Carbinoxamine Drug Products

• FDA News: FDA Acts to Improve Drug Safety and Quality; Manufacturing of Unapproved Drug Products Containing Carbinoxamine Must Cease (Issued June 8, 2006)
• Questions and Answers About Unapproved Drugs and FDA’s Enforcement Action Against Carbinoxamine Products
• Federal Register Notice [HTML] [PDF] (June 9, 2006). FDA announced its intention to take enforcement action against unapproved drug products containing carbinoxamine and persons who cause the manufacture of such products.

Neil Laboratories, Inc.

• Warning Letter (Issued May 31, 2006)

Scientific Laboratories, Inc.

• Warning Letter (Issued November 16, 2005)

Pharmakon Laboratory, Inc.

• FDA News: FDA Blocks Sale of Illegal Drugs: U.S. District Judge Issues Injunction Against Florida Company (Issued July 27, 2005)
• Court Opinion (July 25, 2005)
• Order of Permanent Injunction (July 25, 2005)
• FDA Amended Complaint for Injunction (September 14, 2004)
• Warning Letter (Issued September 7, 2001)

Propharma, Inc.

• Consent Decree of Permanent Injunction (November 23, 2004)
• FDA Complaint for Permanent Injunction (November 19, 2004)

Lane Labs-USA, Inc.

• FDA News: U.S. District Judge Issues Permanent Injunction Against Lane Labs-USA, Inc. and Orders Firm to Refund Money to Purchasers of Illegally Marketed Unapproved Drugs (Issued July 13, 2004)
• Appellate Court Opinion (July 30, 2005)
• Order of Permanent Injunction (July 9, 2004)
• FDA Talk Paper: FDA Takes Action Against Firm Marketing Unapproved Drugs (Issued December 10, 1999)
• Warning Letter (Issued September 24, 1997)

Exocrine Pancreatic Insufficiency Drug Products

• FDA News: FDA Requires Pancreatic Extract Manufacturers to Submit Marketing Applications (Issued April 27, 2004)
  
  
• Questions and Answers on Exocrine Pancreatic Insufficiency Drug Products (April 27, 2004)
  
  
• Federal Register Announcement [HTML] [PDF] (April 28, 2004). FDA announced that all exocrine pancreatic insufficiency drug products are new drugs and announced the conditions for continued marketing of these drug products.
  
  
• Federal Register Notice of Availability [HTML] [PDF] (April 14, 2006). FDA announced the availability of a guidance for industry entitled ‘‘Exocrine Pancreatic Insufficiency Drug Products—Submitting NDAs.’’ This guidance intended to assist manufacturers of exocrine pancreatic insufficiency drug products in preparing and submitting documentation to meet new drug application (NDA) requirements for the drug products.
  
  
• Guidance Document: Exocrine Pancreatic Insufficiency Drug Products--Submitting New Drug Applications (April 14, 2006)

Carolina Pharmaceutical, Inc.

• Warning Letter (Issued March 12, 2004)

Forest Laboratories, Inc.

• Warning Letter (Issued August 7, 2003)

Single Ingredient Extended Release Guaifenesin Drug Products

• FDA Talk Paper: FDA Issues Letter Discussing its Enforcement Policy for Unapproved Drugs (Issued February 26, 2003)
• Warning Letters, Volume 1 (Issued October 11, 2002)
• Warning Letters, Volume 2 (Issued October 11, 2002)

Digoxin Products for Oral Use

• Federal Register Notice [HTML] [PDF] (November 24, 2000).  FDA reaffirmed its determination that digoxin products for oral use (tablets and elixir) are new drugs and announced the conditions for marketing the products.  In the same Federal Register issue, FDA published a proposed rule to revoke the regulations that establish conditions for marketing digoxin products for oral use. [HTML] [PDF]
  
  
• Federal Register Notice [HTML] [PDF] (June 26, 2002).  FDA published a final rule revoking the regulation establishing conditions for marketing digoxin products for oral use.

Sage Pharmaceuticals, Inc.

• Appellate Court Opinion [external link] (April 20, 2000)
• Order of Permanent Injunction (August 10, 2000)
• Warning Letter (Issued April 26, 1995)

• Federal Register Announcement [HTML] [PDF] (August 14, 1997). FDA announced that orally administered levothyroxine sodium drug products are new drugs.
  
  
• Federal Register Announcement [HTML] [PDF] (April 26, 2000). FDA announced that manufacturers who were marketing orally administered drug products containing levothyroxine sodium on or before August 14, 1997, may continue to market these products without approved applications until August 14, 2001. The agency took this action to give manufacturers additional time to conduct studies and to prepare applications.
  
  
• Federal Register Notice of Availability [HTML] [PDF] (July 13, 2001). FDA announced the availability of a guidance for industry entitled ‘‘Levothyroxine Sodium Products—Enforcement of August 14, 2001, Compliance Date and Submission of New Applications.’’ This guidance discusses how FDA plans to exercise its enforcement discretion after August 14, 2001, with regard to levothyroxine sodium products that are marketed without approved applications. This guidance also answers certain frequently asked questions concerning the submission of applications for levothyroxine sodium products.
  
  
• Guidance Document: Levothyroxine Sodium Products Enforcement of August 14, 2001, Compliance Date and Submission of New Applications [HTML] [PDF]
  
• FDA Talk Paper: FDA Issues Guidance on Levothyroxine Sodium Products Compliance (Issued July 12, 2001)
   

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Date created: June 8, 2006, updated May 22, 2008

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