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Alembic Pharma JV bags USFDA nod for Efinaconazole Topical Solution
Vadodara: Alembic Pharmaceuticals Limited has recently announced that the company's joint venture Aleor Dermaceuticals Limited 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...
Vadodara: Alembic Pharmaceuticals Limited has recently announced that the company's joint venture Aleor Dermaceuticals Limited 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 Topical Solution, 10% is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
Efinaconazole Topical Solution, 10% has an estimated market size of US$ 233 million for twelve months ending December 2020 according to IQVIA.
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.
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat.
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751