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COPLEY PHARMACEUTICALS' ALBUTEROL SULFATE 0.5% SOLUTION CLEARED

Executive Summary

COPLEY PHARMACEUTICALS' ALBUTEROL SULFATE 0.5% SOLUTION CLEARED BY FDA as one of four first generic approvals in the month of November. The generic version of Schering's Proventil and Glaxo's Ventolin solutions for nebulization was approved on Nov. 27. Copley said that it will begin shipping and advertising the bronchodilator in January. There are still no approved generics for the popular metered- dose inhaler form of albuterol sulfate because of FDA's concerns that early studies submitted by manufacturers did not demonstrate bioequivalence. FDA is expected to issue a bioequivalence guidance for albuterol sulfate metered dose inhalers by mid-1992 ("The Pink Sheet" Oct. 21, T&G-11). The average wholesale price of the Copley product is $ 12.50 compared to the Proventil and Ventolin AWPs of $ 14.86 for 0.5% solution of 20 ml listed in the November 1991 "Red Book." Copley says it expects the generic version to generate $ 3 mil. in sales next year in the "$ 44 mil." U.S. prescription nebulized albuterol market. The second first-time generic approval in November was Mutual Pharmaceutical's tolmetin sodium 200 mg tablets and tolmetin sodium 400 mg capsules (McNeil's Tolectin and Tolectin DS, respectively), which were approved on Nov. 27. Mutual began shipping immediately. Novopharm, Ltd. received a simultaneous approval for the 400 mg capsule formulation of the nonsteroidal anti-inflammatory agent, which is used to relieve pain from arthritis. The fourth approval, also on Nov. 27, was for EntraVision's Endosol-Plus. The product is a generic version of Alcon's BSS Plus, a balanced salt solution enriched with bicarbonate, dextrose and glutathione that is used as an ophthalmic irrigating solution during surgical procedures. Clearing their desks for the long Thanksgiving weekend, FDA generic drug reviewers approved 11 generic products on Nov. 27 (see ANDA chart, T&G-14). The 11 new approvals bring the total number of products approved by the generic division in November to 16 and the number of ANDAs and AADAs to 21. The total for October was also 21 ANDAs. Year-to-date, FDA has approved 166 ANDAs and AADAs.

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