LILLY TO MARKET FOUR ANDAed DOSAGE FORMS OF CEFUROXIME (GLAXO's ZINACEF)
Executive Summary
LILLY TO MARKET FOUR ANDAed DOSAGE FORMS OF CEFUROXIME (GLAXO's ZINACEF) under the same non-exclusive license that allowed the firm to challenge Glaxo's exclusive marketing of ceftazidime. On Jan. 10, Lilly received three separate antibiotic Form 6 ANDA approvals for different dosage forms of cefuroxime to be marketed under the brandname Kefurox. Subsequently, on Jan. 15, Lilly received an additional approval for cefuroxine in Abbott's Add-Vantage system. Lilly indicated that neither a launch date nor pricing have been finalized. Cefuroxime represents Lilly's second ANDA approval of a Glaxo third generation cephalosporin in the past three months. Shortly after Glaxo introduced Fortaz (ceftazidime) last July, Lilly went the ANDA route with its own ceftazidime product, Tazidime, under a 1969 cross-licensing agreement with Glaxo. Despite a Glaxo citizen petition to FDA contending that ceftazidime exclusivity was implicitly covered by Title I of the Waxman/Hatch Law, Lilly received Tazidime approval Nov. 20 ("The Pink Sheet" Nov. 25, p. 5). At an April 1985 analysts meeting, Glaxo announced its intention to file for an oral form of cefuroxime ("The Pink Sheet" April 15, p. 12). The application is now pending. Lilly is also asserting that rights to the oral form should also be provided by the 1969 nonexclusive Lilly/Glaxo agreement.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
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 Skin Infections Guidance Spurs Debate On Endpoint Relevance
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
Shire Hopes To Sow Future Deals With $50M Venture Fund
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