In Brief: Pfizer cetirizine
Pfizer cetirizine: "Approvable" as of Feb. 21 for seasonal allergic rhinitis, perennial allergic rhinitis and chronic urticaria. Pfizer's oral antihistamine (NDA 19-835) was recommended for approval for those indications at an April 1993 FDA Pulmonary-Allergy Drugs Advisory Committee meeting. The drug is marketed elsewhere as Zyrtec; Pfizer has referred to the therapy as Reactine, but the final product name is still under discussion with FDA and should be determined within the next two months, Pfizer says. Pfizer has a trademark, Certex-24, in registration with the PTO for an anti-allergy product...
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