Drugs

Unapproved Prescription Drugs: FDA Actions

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Since publication of the Compliance Policy Guide (CPG) for Marketed Unapproved Drugs (drugs marketed without approved NDAs and ANDAs) (CPG Sec. 440.100), the FDA has taken compliance and enforcement actions against a number of companies that market unapproved prescription drugs.

Abraxis Bioscience, Inc.

Actavis Totowa, LLC

Amerifit Brands, Inc.

ANIP Acquisition Company

Bryant Ranch Prepac

Cispharma, Inc.

Claris Lifesciences Limited

Concord Laboratories, Inc.

Contract Pharmacal Corporation

C. R. Canfield Co., Inc.

Crescendo Therapeutics, LLC

  • FDA News: U.S. Marshals seize Crescendo Therapeutics HybriSil Gel (May 22, 2012)

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Deltex Pharmaceuticals Inc.

Dental Technologies, Inc.

Deston Therapeutics

Elge, Inc.

G & W Laboratories, Inc.

Hi-Tech Pharmacal Co., Inc.

Hill Dermaceuticals, Inc.

IriSys, Inc.

Keystone Pharmaceuticals

KV Pharmaceutical Company

Laclede, Inc.

McGuff Pharmaceuticals, Inc.

Midland Pharmaceutical LLC

Neil Laboratories, Inc.

Neilgen Pharmaceuticals, Inc.

Nexgen Pharma, Inc.

Ohm Laboratories, Inc.

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PharmaFab Inc.

Pharmakon Laboratory, Inc.

Pharma Pac Inc.

PrimaPharm Inc.

Provident Pharmaceuticals LLC

Recsei Laboratories, LLC

River's Edge Pharmaceuticals, LLC

RGH & Company Inc., dba Vital Nutrients

Scientific Laboratories, Inc.

Shamrock Medical Solutions Group, LLC

Sheffield Laboratories, Division of Faria Limited LLC

Sovereign Pharmaceuticals, LLC

Sunrise Pharmaceutical, Inc.

Syntho Pharmaceuticals, Inc. and Intermax Pharmaceuticals, Inc.

Time-Cap Laboratories, Inc.

Tri-Med Laboratories, Inc.

  • Warning Letter (February 23, 2010)
  • Consent Decree of Permanent Injunction (PDF - ) (March 2011)

Vintage Pharmaceuticals, LLC

Vita-Erb, Ltd.

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Page Last Updated: 12/11/2014
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