COPLEY PHARMACEUTICALS' ALBUTEROL SULFATE 0.5% SOLUTION CLEARED
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.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth