(Corrects headline to clarify that the FDA is seeking more
information, not Theravance)
Oct 22 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)