Merck Maxalt migraine therapy NDA filing is imminent, company indicates.
Executive Summary
MERCK MAXALT NDA FILING FOR MIGRAINE TREATMENT PLANNED BY END OF JUNE, the company indicated. The NDA for Maxalt (rizatriptan) will encompass two dosage forms and two doses of Maxalt: 5 mg and 10 mg doses in a tablet formulation and a Rapidisc "wafer that disintegrates in the mouth" using R.P. Scherer's Zydis technology. The wafer offers a convenience benefit, Merck said; the company believes the two dosage forms are comparable. The 10 mg dose will "be recommended as the primary dose," Merck said.
You may also be interested in...
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
Shire Hopes To Sow Future Deals With $50M Venture Fund
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