Alembic Pharma share price jumps 3% on tentative USFDA approval

Alembic has a cumulative total of 140 ANDA approvals (123 final approvals and 17 tentative approvals) from USFDA.

April 08, 2021 / 11:36 AM IST
 
 
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Alembic Pharmaceuticals share price added more than 3 percent intraday on April 8 after the company's JV with Aleor Dermaceuticals received tentative approval from the US Food & Drug Administration (USFDA).

Company today announced that its joint venture Aleor has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Efinaconazole Topical Solution, 10%.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Jublia Topical Solution, 10%, of Bausch Health Americas, Inc.

Efinaconazole is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton

mentagrophytes.

Efinaconazole has an estimated market size of USD 233 million for twelve months ending December 2020 according to IQVIA.

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Aleor has settled the case with Bausch Health and will launch its generic as per the terms of settlement.

Alembic has a cumulative total of 140 ANDA approvals (123 final approvals and 17 tentative approvals) from USFDA.

At 10:51 hrs Alembic Pharmaceuticals was quoting at Rs 993.65, up Rs 20.40, or 2.10 percent on the BSE.
Moneycontrol News
first published: Apr 8, 2021 11:36 am

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