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Executive Summary

CHELSEA REQUESTING WITHDRAWAL OF 20 ANDAS covering 22 dosage strengths. "In a letter dated Nov. 4, 1991, Chelsea requested that FDA withdraw" the applications, the agency said in a Dec. 5 Federal Register notice. The products and 22 dosage strengths involved are metronidazole (250 mg/500 mg), allopurinol (100 mg/300 mg), propranolol (10/20/40/60/80 mg), methyldopa (125/250/500 mg), metoclopramide (10 mg), diazepam (2/5/10 mg), thiothixene (2/5/10 mg), meclofenamate (50/100 mg) and verapamil (40 mg). In addition, Chelsea has agreed to withdraw ANDAs for 31 other product strengths for which FDA previously had proposed withdrawal. Federal Register notices on Dec. 3 and Dec. 5 announced the withdrawal of 22 of the strengths. A notice on the final nine products has yet to be published. "Chelsea has contested approval withdrawals on the ground that the manufacturing variations in the records were minor and, according to experts with whom it consulted, not material to the safety, effectiveness or quality of the products," Chelsea said. However, the company "has determined that the most efficient use of its resources is to terminate at this early stage what would be protracted administrative litigation and to submit new applications for those products in which it maintains an interest." The 31 products for which Chelsea has withdrawn hearing requests are: chlorothiazide (500 mg), disopyramide (100/150 mg), doxepin (10/25/50/75/100/150 mg), ibuprofen (200/400/600/800 mg), oxazepam (10/15/30 mg), perphenazine (8 mg), perphenazine/amitriptyline (2-10/2-25/4-10/4-25/4-50 mg), propoxyphene/acetaminophen (50-325/100-650 mg), tolazamide (100/250/500 mg), trazodone (50/100 mg) and verapamil (80 mg and 120 mg). FDA proposed the withdrawals based on "untrue statements, discrepancies, and omissions that relate to batches of drug products used to support approval" of the applications, the Federal Register notice says. Chelsea noted that FDA's conclusions were reached "on the basis of company audit findings and [FDA's] own evaluation of the records." Chelsea decided to withdraw the applications for which FDA had not initiated proceedings "because of the similarity of audit findings" for those products. Chelsea initiated a Class II recall of the 53 products at the beginning of November, the company said. Because the company had stopped manufacturing the suspect products as early as February 1990, it believes little product remains on the market. The Class II designation of the recall, which implies a safety hazard, is in keeping with FDA's policy that all recalls due to submissions containing misstatements, should be designated Class II. Chelsea maintained that "the inaccuracies [in its applications] do not raise explicit safety concerns." FDA demonstrated its willingness to insist on Class II status in its recent negotiations with PBI, where the agency ultimately filed seizure actions on some products before the generic drug firm agreed to a Class II recall ("The Pink Sheet" Nov. 18, T&G-8). Chelsea previously has recalled two products for ANDA discrepancies: doxycycline 100 mg and ergoloid mesylates 1 mg ("The Pink Sheet" April 9, 1990, T&G-10). The company subsequently withdrew those two ANDAs as well. Chelsea maintains that its November actions have cleaned the slate of all inaccurate submissions. Chelsea, a Rugby-Darby subsidiary, continues to manufacture about 70 products of which about 60 are covered by ANDAs, with the remainder being either OTC or grandfathered generics. The company's remaining products and pending applications have cleared internal and external audits, Chelsea said.

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