You are here

Tentative Approval Granted for Sumatriptan Succinate

PITTSBURGH, May 24 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. Food and Drug Administration has granted tentative approval for Mylan Pharmaceuticals Inc.'s Abbreviated New Drug Application for Sumatriptan Succinate Tablets 25 mg (base), 50 mg (base) and 100 mg (base).

Sumatriptan Succinate Tablets are indicated for the acute treatment of migraine headaches. They are the generic version of GlaxoSmithKline's Imitrex® Tablets, which had annual U.S. sales of approximately $878 million as of March 31, 2006.

Source: Mylan Laboratories Inc.

Recent Headlines

Potential contamination could lead to supply chain disruptions
Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs