In Brief: Pharmacia & Upjohn OTC Rogaine Extra Strength
Pharmacia & Upjohn OTC Rogaine Extra Strength: FDA's Nonprescription and Dermatologic & Ophthalmic Drugs Advisory Committees recommend OTC approval of 5% strength minoxidil solution for men July 16. P&U initially submitted an NDA in December 1995 as an Rx product, which was deemed "approvable" a year later. In February P&U proposed that the 5% product go OTC directly. Committees determine P&U claim that Rogaine 5% produces "more hair growth" than the currently marketed 2% product is supported, but P&U claim that the 5% solution leads to "faster" hair growth needs further data. P&U is pursuing approval of Rogaine Extra Strength for women separately...
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