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QUANTUM LEAPS INTO BENZODIAZEPINE MARKET WITH LORAZEPAM ANDA APPROVAL FROM FDA

Executive Summary

Quantum Pharmics jumped into the benzodiazepine market with the approval of its lorazepam ANDA by FDA on Aug. 9. The agency approved three dosage forms of the anti-anxiety agent, 0.5 mg, 1 mg, and 2 mg tabs. The generic version of Wyeth's Ativan is the second post-1962 ANDA approval in two weeks for the Amityville, NY-based Quantum Pharmics. On July 29, the company received approval to market the gastric motility agent metoclopramide (10 mg tabs), the generic to Robins Reglan. HHS highlighted the lorazepam approval in a press release Aug. 13, noting that the drug is the sixth post-1962 generic approved since enactment of the ANDA/patent restoration law in November 1984. The other post-1962 drugs that have cleared the agency are dysopyramide, propoxyphene napsylate with acetaminophen, metoclopramide, propranolol HCI and ibuprofen. In all, 12 separate ANDA's for the post 1962 products have been approved. The HHS release said Ativan "ranks 22 in the top 100 selling drugs in the U.S. with 1984 sales of about" $150 mil. Pharmaceutical Data Services projected 1984 Ativan sales in the U.S. at $102 mil. at pharmacy cost. With the lorezapam approval, American Home Products' top two Rx products have become multisource drugs within a two week period. On July 30, Lederle and Chelsea received ANDA approval for generic propranolol, which Lederle said it would sell for 30-35% less than American Home's brand name product, Inderal. In addition, Martec received an ANDA for propranolol on Aug. 6. Zenith is now marketing the Martec product.

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