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VITARINE's ST. CROIX MANUFACTURING RECORD DISCREPANCIES CITED BY FDA

Executive Summary

VITARINE's ST. CROIX MANUFACTURING RECORD DISCREPANCIES CITED BY FDA in an Oct. 3 Federal Register notice proposing to withdraw 25 of Vitarine's ANDAs. FDA said that records from the company show that certain batches submitted in support of the abbreviated antibiotic applications (AADAs) for cephadrine capsules and cephalexin tablets "were purportedly made during a time when the St. Croix facility was reportedly inactive," FDA maintained. FDA notified the company in August that it would be formally proposing the withdrawal of the ANDAs, because they contained "untrue statements of material fact" ("The Pink Sheet" Aug. 28, p. 8). Most of the ANDA revocations currently being proposed are based on discrepancies in batch size, falsification of batch records or absence of batch records. The proposed withdrawals are for: baclofen tabs 10 and 20 mg; cephadrine caps 250 and 500 mg; cephalexin caps 250 and 500 mg; cephalexin tabs 250, 500, and 1,000 mg; cephalexin oral suspension 125 mg/5 ml and 250 mg/5 ml; clindamycin HCI caps 75 and 150 mg; desipramine HCl tabs 10 and 150 mg; doxycycline hyclate 50 and 100 mg; triamterene 75 mg/hydrochlorothiazide 50 mg tabs; indomethacin ER caps 75 mg; indomethacin caps 25 and 50 mg; meclofenamate caps 50 and 100 mg; mefenamic acid caps 250 mg; Orphenadrine Compound, single strength; Orphenadrine Compound Double Strength tabs; tetracycline HCl caps 250 and 500 mg; trimipramine caps 25, 50 and 100 mg. Vitarine suspended distribution of all of the listed products last May after questions were raised about the company's generic Dyazide and other products approved since 1986 ("The Pink Sheet" July 3, p. 13). The company voluntarily agreed that the ANDA approval for Dyazide (triamterene 50 mg/hydrochlorothiazide 25 mg capsules) should be withdrawn and waived its opportunity for a hearing, which was issued in an Aug. 28 Federal Register notice. In the current FDA action, a Vitarine hearing request is due by Nov. 2 and data and information in support of the hearing request is due by Dec. 4. Vitarine is fighting the other ANDA withdrawals. In an Aug. 31 letter to FDA, Vitarine maintained that there is no basis for the withdrawal of the ANDAs because Vitarine has submitted "rectifying data" on a number of the products. The FDA action would require Vitarine to make complete resubmissions of the 25 ANDAs, rather than simply supplementing the old applications. * A Federal Register notice proposing the withdrawal of three Par ANDAs -- generic versions of Maxzide, Orphengesic, and Orphengesic Forte -- is imminent and may show up in the Federal Register the week of Oct. 9. FDA will also propose the withdrawal of Bolar's generic Dyazide, due to questions of bioequivalence, in the next two to three weeks. That action is expected to be hotly contested, as the company has already met several times with FDA to head off such a decision ("The Pink Sheet" Oct. 2, p.17). Bolar continues to market Dyazide. FDA has dropped the therapeutic equivalence rating for the Bolar product from "AB" to "BX," or therapeutically inequivalent to the brandname product.
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PS016370

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