Newspaper article St Louis Post-Dispatch (MO)

Kv Loses Right to Make 3 Drugs Fda's Revocation Ends 2-Year-Old Dispute

Newspaper article St Louis Post-Dispatch (MO)

Kv Loses Right to Make 3 Drugs Fda's Revocation Ends 2-Year-Old Dispute

Article excerpt

The Food and Drug Administration has revoked permission for KV Pharmaceutical Co. to make three prescription drugs, ending a dispute that began in 1993.

KV submitted "untrue statements" in some test data and selectively reported some test results, the agency said. As a result, the FDA added, the drugs "lack substantial evidence of effectiveness."

Revocation notices are rare: The FDA issued only two to makers of drugs for human use in 1993, the last year for which data was available.

The FDA told KV in June 1993 and November 1993 that it was taking action against the company. The agency issued a final notice in late June, giving KV the right to appeal.

Although KV asked for a hearing, it wrote the FDA Aug. 25 withdrawing its request, according to a government document obtained by the Post-Dispatch.

The letter from KV's law firm said KV disagreed with the reasons cited for revocation, adding that "the products are no longer being marketed." KV stopped making each drug several years ago. …

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