Allergan Restasis
Executive Summary
Company receives "approvable" letter for .05% cyclosporine ophthalmic emulsion. The NDA is being reviewed for treatment of moderate to severe keratoconjunctivitis sicca. FDA's Dermatologic & Ophthalmic Drugs Advisory Committee voted against approval July 21, but said that completed extension phases of two U.S. Phase III trials could provide additional evidence of a clinical effect (1"The Pink Sheet" July 26, p. 5)
You may also be interested in...
Allergan Restasis Extension, European Studies Could Support Approval
Completed extension phases of two U.S. Phase III trials of Allergan's Restasis could provide additional evidence of a clinical effect for the dry eye therapy, FDA's Dermatologic & Ophthalmic Drugs Advisory Committee ophthalmic subcommittee said July 21.
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