FDA, Federal Agents Seize $24.2 Million in Unapproved New Drugs

Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service yesterday seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.

The seizure followed an inspection of several of the company's plants where FDA investigators found that the company was not complying with an FDA enforcement notice, as well as manufacturing unapproved new drugs such as products for coughs, colds, topical wound healing, skin bleaching, and gastrointestinal conditions, as well as narcotic drug products.

"The FDA is committed to taking enforcement action against firms that circumvent the drug approval process," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research. "Consumers need to be confident that the drugs and medical products they use are safe and effective, and the FDA will take the necessary measures to ensure safety and effectiveness throughout the lifecycle of the product, including keeping the product from reaching the marketplace."

In a routine inspection of KV Pharmaceutical's facilities in early 2008, FDA found the company was violating its May 29, 2007, notice (72 FR 29517) requiring companies to stop manufacturing all timed-release drug products containing guaifenesin, including combination drug products in which guaifenesin is in immediate release form, but another ingredient in the combination drug product is in timed-release form, because they are unapproved new drugs.

FDA took the action as part of its effort to ensure that all drugs marketed in the United States have the required FDA approval and that they are safe, effective, of good quality, and are appropriately labeled. For products in timed-release form, FDA approval is also necessary to make sure that the product releases its active ingredients at the correct rate. Improperly manufactured timed-release products may release the active ingredients too quickly, too slowly, or not at all, making the product unsafe or ineffective.

FDA required companies to stop manufacturing the affected products before Aug. 27, 2007, and to stop shipping the products before Nov. 26, 2007. KV Pharmaceutical continued to manufacture and ship these unapproved new drugs after the cessation dates.

The inspection also exposed the company's manufacturing and distribution of other unapproved drug products. The following drug products were seized and will be destroyed: PhenaVent Capsules, PhenaVent LA Capsules, PhenaVent PED Capsules, Ethezyme Papain-Urea Ointment, Ethezyme 650 Papain-Urea Ointment, Ethezyme 830 Papain-Urea Ointment, Hista-Vent DA Tablets, Meperidine/Promethazine Capsules, Pseudovent Capsules, Pseudovent 400 Capsules, Pseudovent PED Capsules, Tri-Vent DM Syrup, Tri-Vent DPC Syrup, Hydro-Tussin DM Liquid, Hydro-Tussin CBX Syrup, Hydro-Tussin DHC Syrup, Hydro- Tussin EXP Syrup, Hydro-Tussin HD Syrup, Hyoscyamine Sulfate Sublingual Tablets, Hydroquinone 4% Cream, Hydroquinone 4% Cream with Sunscreen, Bromfenex Extended Release Capsules, and Bromfenex PD Extended Release Capsules.

The seized drugs had been held under embargo by the state of Missouri. Since the time of the embargo, KV Pharmaceutical has been cooperating with FDA officials.

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