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Alembic Wins FDA Approval For Betamethasone Foam

Alembic gets USFDA approval for Betamethasone Valerate Foam, expanding its topical corticosteroid portfolio.

Par Mrudula Kulkarni

Rédacteur en chef - Pharma Now

26 août 2024Updated Jun 26, 2025 · 2 min de lecture

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Alembic Wins FDA Approval For Betamethasone Foam — https://www.clinicalleader.com/doc/new-manuscript-examines-fda-s-use-of-rwe-in-drug-approvals-0001

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Reviewed by Mrudula Kulkarni, Rédacteur en chef - Pharma Now

Alembic Pharmaceuticals Limited (Alembic) has secured final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Betamethasone Valerate Foam, 0.12%. This newly approved ANDA is a therapeutic equivalent to Luxiq Foam, 0.12%, the reference listed drug (RLD) produced by Norvium Bioscience, LLC.

Betamethasone Valerate Foam, 0.12% is classified as a medium-potency topical corticosteroid, prescribed to alleviate inflammation and itching associated with corticosteroid-responsive dermatoses of the scalp. For detailed usage instructions, please refer to the product label. With this approval, Alembic now has a total of 213 ANDA approvals from the USFDA, comprising 185 final approvals and 28 tentative approvals.

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Written by

Mrudula Kulkarni

Rédacteur en chef - Pharma Now

My international experience as a researcher in Taiwan for three years has equipped me with a global perspective, enabling me to create content that resonates with an international audience.