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Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval
Enforcement Actions
Enforcement Actions
Since the CPG, FDA has removed numerous unapproved drug products from the market. Generally, the Agency has focused its enforcement efforts on classes of unapproved drugs or firms marketing unapproved drugs.
Drug-Based Actions: Since publication of the CPG, the Agency has taken enforcement action against a number of unapproved drugs:
Balanced Salt Solution (ophthalmic) Products Drug Products
Carbinoxamine Drug Products
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)
Timed-Release Drug Products Containing Guaifenesin
Hydrocodone Drug Products
Injectable Colchicine Products
Topical Drug Products Containing Papain
Quinine Sulfate Drug Products
Trimethobenzamide Hydrochloride Suppositories
- Federal Register Notice [HTML] [PDF ] (April 9, 2007)
- FDA News: FDA Announces that Companies Must Stop Marketing Suppository Products Containing Trimethobenzamide (Issued April 6, 2007)
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Firms
In addition, since publication of the CPG, the Agency has taken enforcement actions against a number of firms with significant violations of current good manufacturing practice (CGMPs) or adverse event reporting requirements that also make unapproved drugs.
- Abraxis Bioscience, Inc.
- Actavis Totowa, LLC
- Amerifit Brands, Inc.
- Concord Laboratories, Inc.
- C. R. Canfield Co., Inc.
- Elge, Inc.
- G & W Laboratories, Inc.
- KV Pharmaceutical Company
- Midland Pharmaceutical LLC
- PharmaFab Inc.
- Scientific Laboratories, Inc.
- Sheffield Laboratories, Division of Faria Limited LLC
- Syntho Pharmaceuticals, Inc. and Intermax Pharmaceuticals, Inc.
- TME Enterprises
- Vintage Pharmaceuticals, LLC
- Vita-Erb, Ltd.
Abraxis Bioscience, Inc.
Actavis Totowa, LLC
Amerifit Brands, Inc.
Concord Laboratories, Inc.
C. R. Canfield Co., Inc.
Elge, Inc.
G & W Laboratories, Inc.
KV Pharmaceutical Company
- FDA News: Federal Agents Seize more than $24 Million in Unapproved New Drugs (Issued July 30, 2008)
Midland Pharmaceutical LLC
PharmaFab Inc.
Scientific Laboratories, Inc.
- FDA News: FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc. (Issued May 16, 2008)
Sheffield Laboratories, Division of Faria Limited LLC
Syntho Pharmaceuticals, Inc. and Intermax Pharmaceuticals, Inc.
TME Enterprises
Vintage Pharmaceuticals, LLC
Vita-Erb, Ltd.
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Date created: June 8, 2006; updated September 23, 2008 |
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