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|Federal Agents Seize more than $24 Million in
Unapproved New Drugs July 30, 2008
Products made after the FDA required an end to
Representatives of the U.S. Food and Drug Administration
and the U.S. Marshals Service today 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.
"American consumers are entitled to have safe and
effective drugs," said Hanaway.
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 cough, cold, 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 (CDER). "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, the 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
The FDA required companies to stop manufacturing the
affected products before August 27, 2007, and to stop
shipping the products before November 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.
Today's action addresses numerous unapproved drug
products manufactured and distributed by the company.
The following drug products were seized and will be
* 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 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.
"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, director of the FDA's Office of Compliance within
CDER. "When a company does not heed a cessation date
relating to a specific product, the FDA will take
enforcement action relating to the company's other
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 encourages consumers who may have these
products to contact their health care professional about
FDA-approved treatments and discard these products.
Federal Agents Seize more than $24 Million in Unapproved
New Drugs, FDA News, July 30, 2008