Goserelin acetate 3.6 mg depot and 10.8 mg depot approved July 27 for use in combination with flutamide (Schering-Plough's Eulexin) for the management of locally confined stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Zeneca filed supplemental NDAs 19-726/S-024 and 20-578/S-003 on Aug. 11, 1997 for the new indication for the depot formulations. Zoladex was previously approved as monotherapy for advanced prostate cancer
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