KV Pharmaceutical Press Release

July 29, 2008
For Immediate Release

FEDERAL AGENTS SEIZE MORE THAN $24 MILLION IN UNAPPROVED NEW DRUGS FROM KV PHARMACEUTICAL IN BRIDGETON

St. Louis, MO: Representatives of the U.S. Food and Drug Administration and U.S. Marshal's Service today began seizing $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, United States Attorney Catherine L. Hanaway announced today.

Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant from the U.S. District Court for the Eastern District of Missouri to seize the unapproved new drug products being made by KV Pharmaceutical.

“American consumers are entitled to have safe and effective drugs,” said Hanaway. “The majority of the products being seized were made after the FDA required an end to their production.”

Today’s seizure followed an FDA inspection of several of the company’s plants earlier this year where investigators found that the company was not complying with an FDA enforcement notice warning that drugs in time-release format containing guaifenesin, an expectorant, must be approved by the FDA to ensure the safe and effective release of the active ingredients. The FDA required companies to stop manufacturing the affected products before August 27, 2007, and to stop shipping the products before Nov. 26, 2007. In violation of the FDA cessation dates, the company continued to manufacture and distribute the unapproved drugs. The inspectors also found that the company was manufacturing and distributing other unapproved new drugs, such as products for cough, cold, topical wound healing, skin bleaching and gastrointestinal conditions.

"The FDA will take action against companies that continue to manufacture or market an unapproved product after the marketing or distribution cessation date,” said Deborah M. Autor, Esq., director of the FDA’s Office of Compliance in the Center for Drug Evaluation and Research (CDER). In June 2006, the FDA issued a guidance document titled, "Marketed Unapproved Drugs—Compliance Policy Guide (CPG).” This CPG makes clear that companies may not market drugs that require approval without first establishing, through applications for approval, that the products are safe and effective. “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 (CDER).

The seizure addresses numerous unapproved drug products manufactured and distributed by the company. The following drug products are being seized and are subject to destruction:

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
Bromfenex PD Extended Release Capsules

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

The drugs were sold under the names set forth above, and the labeling would also contain the name KV Pharmaceutical or ETHEX. The FDA encourages consumers who may have these products to contact their health care professional. Because the drugs are unapproved, there is no assurance that the drugs will perform as labeled. The FDA also recommends that the consumer should discard these products.

Additional Documentation:

Note: The above documents are in Adobe Acrobat (.pdf) format. If you do not have the Adobe Acrobat Reader on your computer, click below to be directed to the Adobe website for a free download.

UNITED STATES ATTORNEY'S OFFICE EASTERN DISTRICT OF MISSOURI CATHERINE L. HANAWAY United States Attorney	NEWS RELEASE
For further information: Call Public Affairs Officer Jan Diltz at (314) 539-7719
July 29, 2008 For Immediate Release FEDERAL AGENTS SEIZE MORE THAN $24 MILLION IN UNAPPROVED NEW DRUGS FROM KV PHARMACEUTICAL IN BRIDGETON St. Louis, MO: Representatives of the U.S. Food and Drug Administration and U.S. Marshal's Service today began seizing $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, United States Attorney Catherine L. Hanaway announced today. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant from the U.S. District Court for the Eastern District of Missouri to seize the unapproved new drug products being made by KV Pharmaceutical. “American consumers are entitled to have safe and effective drugs,” said Hanaway. “The majority of the products being seized were made after the FDA required an end to their production.” Today’s seizure followed an FDA inspection of several of the company’s plants earlier this year where investigators found that the company was not complying with an FDA enforcement notice warning that drugs in time-release format containing guaifenesin, an expectorant, must be approved by the FDA to ensure the safe and effective release of the active ingredients. The FDA required companies to stop manufacturing the affected products before August 27, 2007, and to stop shipping the products before Nov. 26, 2007. In violation of the FDA cessation dates, the company continued to manufacture and distribute the unapproved drugs. The inspectors also found that the company was manufacturing and distributing other unapproved new drugs, such as products for cough, cold, topical wound healing, skin bleaching and gastrointestinal conditions. "The FDA will take action against companies that continue to manufacture or market an unapproved product after the marketing or distribution cessation date,” said Deborah M. Autor, Esq., director of the FDA’s Office of Compliance in the Center for Drug Evaluation and Research (CDER). In June 2006, the FDA issued a guidance document titled, "Marketed Unapproved Drugs—Compliance Policy Guide (CPG).” This CPG makes clear that companies may not market drugs that require approval without first establishing, through applications for approval, that the products are safe and effective. “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 (CDER). The seizure addresses numerous unapproved drug products manufactured and distributed by the company. The following drug products are being seized and are subject to destruction: 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 Bromfenex PD Extended Release Capsules The drugs being seized had been held under embargo by the State of Missouri. Since the time of the embargo, KV has been cooperating with FDA officials. The drugs were sold under the names set forth above, and the labeling would also contain the name KV Pharmaceutical or ETHEX. The FDA encourages consumers who may have these products to contact their health care professional. Because the drugs are unapproved, there is no assurance that the drugs will perform as labeled. The FDA also recommends that the consumer should discard these products. Additional Documentation: Federal Register Notice Forfeiture Complaint Sample label of seized drug Note: The above documents are in Adobe Acrobat (.pdf) format. If you do not have the Adobe Acrobat Reader on your computer, click below to be directed to the Adobe website for a free download.