• 19/08/2022 4:33 pm

#Alembic Pharma share price gains 3% on USFDA approval for antifungal

Alembic Pharmaceuticals share price rose nearly 3 percent intraday on August 13 after the company’s JV received tentative approval from the US drug regulator for an antifungal drug.

Aleor Dermaceuticals Limited (Aleor) has got the US Food and Drug Administration’s tentative approval for its abbreviated new drug application (ANDA) Tavaborole Topical Solution 5%.

It is therapeutically equivalent of Kerydin Topical Solution, 5%, of Anacor Pharmaceuticals, Inc. (Anacor).

Tavaborole is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.

Tavaborole has an estimated market size of $82 million for 12 months ending June 2020, according to IQVIA.

The company is in litigation with Anacor in Delaware and the drug launch will depend on its outcome.

Alembic has a cumulative 128 ANDA approvals (112 final approvals and 16 tentative approvals) from USFDA.

At 1203 hours, Alembic Pharmaceuticals was quoting at Rs 1,087.90, up Rs 11.70, or 1.09 percent, on the BSE.

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