"Approvable" letter received for frovatriptan. FDA is requesting additional data from an ongoing preclinical study involving higher-than-previous doses in mice and supplementary data from long-term pharmaceutical stability and clinical studies of the drug. Submission of the data is anticipated by the end of the third quarter. An NDA for the anti-migraine drug was submitted in January 1999 by Vanguard Medical Group, which licensed North American rights for the product to Elan
You may also be interested in...
Vanguard Medica has found a serotonin receptor target that has a role in controlling obesity but is not associated with the cardiovascular side effects of Redux, Vanguard CEO Robert Mansfield told the Chase H&Q Investing in Biotechnology Conference May 10 in London.
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