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CORRECTED - CORRECTED-Theravance: FDA seeks more information to OK skin dise
October 22, 2007 / 11:48 AM / 10 years ago

CORRECTED - CORRECTED-Theravance: FDA seeks more information to OK skin dise

(Corrects headline to clarify that the FDA is seeking more information, not Theravance)

Oct 22 (Reuters) - Theravance Inc THRX.O said U.S. health regulators asked for additional clinical information for the approval of telavancin for the treatment of skin diseases.

The U.S. Food and Drug Administration issued an approvable letter to the drug developer, a notice that specifies conditions to be fulfilled before a product is approved.

Theravance and its partner Astellas Pharma US Inc, affiliate of Astellas Pharma Inc (4503.T) said that no additional clinical studies will need to be initiated to respond to the approvable letter. (Reporting by Neha Pathania in Bangalore)

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