TAP Uprima
Executive Summary
Takeda/Abbott joint venture hopes to meet with FDA during second quarter to discuss next steps in development of erectile dysfunction therapy Uprima (apomorphine). In January, Abbott said that TAP expected to meet with FDA during the first quarter to discuss the Uprima NDA, which was withdrawn in June (1"The Pink Sheet" Jan. 22, p. 16)
You may also be interested in...
Biaxin XL Gets 40% Of New Clarithromycin Scripts In December, Abbott Says
Abbott's once-daily Biaxin XL is cannibalizing close to half of the company's clarithromycin franchise, the company told investors during a Jan. 16 fourth quarter earnings call.
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
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: