SAN FRANCISCO (Thomson Financial) - Theravance Inc. said late Wednesday the
Food and Drug Administration accepted as complete for review Theravance's
response to the Oct. 19, 2007, approvable letter for telavancin, an
investigational antibiotic for the proposed treatment of skin infections.
The FDA assigned a Prescription Drug User Fee Act target date of July 21,
the company said.
Theravance said the FDA has indicated that it does not expect to take final
action on the telavancin new drug application prior to completing its further
evaluation of study site monitoring and study conduct in the ATLAS Phase III
program, nor prior to resolution of the manufacturing issues not specifically
related to telavancin cited in the approvable letter.
Shares of South San Francisco, Calif.-based Theravance closed at $12.36 and
rose 8% in after-hours trade.
Gabriel Madway
gm
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