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Ranbaxy gets tentative USFDA nod for nail disorder drug

Our Bureau

New Delhi , June 22

RANBAXY Laboratories Ltd has received tentative approval from the US Food and Drug Administration (FDA) to manufacture and market terbinafine hydrochloride tablets, 250 mg, indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).

Currently, Novartis sells the drug under the brand name Lamisil. The annual market for terbinafine hydrochloride tablets, 250 mg is $678.5 million.

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