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Theratechnologies says FDA delays tesamorelin review date
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Says FDA reschedules meeting to review tesamorelin NDA
Jan 25 (Reuters) - Theratechnologies Inc, a Canadian biotechnology firm, said U.S. health regulators will reschedule its meeting to review its marketing application for tesamorelin to treat excess abdominal fat in HIV-infected patients with lipodystrophy.
The Montreal-based company said the Food and Drug Administration's (FDA) delay is entirely procedural and is not related to the marketing application submitted in May last.
The meeting was originally scheduled for Feb. 24 and the FDA is to complete its review of the New Drug Application (NDA) by March 29 under the Prescription Drug User Fee Act.
Theratechnologies shares, which have surged 81 percent in the last three months, were down 13 Canadian cents at C$4.94 in late morning trade Monday on the Toronto Stock Exchange. They touched a low of C$4.88 in early trade. (Reporting by R. Manikandan in Bangalore; Editing by Gopakumar Warrier)
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