FDA DOWNGRADING BIOEQUIVALENCE RATINGS OF FOUR FIRMS' GENERIC DRUGS
FDA DOWNGRADING BIOEQUIVALENCE RATINGS OF FOUR FIRMS' GENERIC DRUGS from AB (bioequivalent) to BX (inequivalent) while the agency begins procedures to withdraw their ANDA approvals. The four firms are Superpharm, Quantum Pharmics, Par, and Vitarine. The generic products affected include three strengths of Superpharm's diazepam and 25 Quantum products. The firms were notified by FDA on Dec. 14 of the new rating and on Nov. 15 of the ANDA withdrawal plan. FDA reported that Quantum "voluntarily agreed to give up" its 25 ANDA approvals on Nov. 27. The agency also announced that Superpharm on Dec. 7 initiated a voluntary recall of its diazepam products and all lots of its ibuprofen 400 mg tablets, due to "discrepancies in the bioavailability information submitted in its application." Also affected are Par's orphengesic and orphengesic forte tablets and triamterene/hydrochlorothiazide tablets and 29 Vitarine ANDAs. FDA told the firms of the rating change Dec. 7 and of the ANDA withdrawal plan on Aug. 22. FDA has already announced downgrading Bolar's generic versions of Dyazide, and Macrodantin. Bolar "voluntarily relinquished approval" for the latter product Dec. 7, FDA noted.
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