By Angela Chen
Antares Pharma Inc. (ATRS) said the U.S. Food and Drug
Administration denied its abbreviated new drug application for its
generic migraine treatment.
The agency's complete response letter detailed labeling
revisions and minor deficiencies, Antares said. A representative
for the FDA wasn't immediately available for comment.
Abbreviated new drug applications are submitted for new generic
drugs. If approved, the migraine treatment, called Sumatriptan
Injection USP, would be Antares' first abbreviated new-drug
application approval and the second one approved from its
auto-injector platform.
New Jersey-based Antares focuses on self-administered drugs
delivered through technologies such as its auto-injector.
If approved, Teva Pharmaceutical Industries Ltd. (TEVA) will
distribute Sumatriptan Injection USP and share profits equally.
Shares of Antares, which were inactive premarket, have declined
about 49% in the past 12 months through Friday's close.
Write to Angela Chen at angela.chen@wsj.com
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