Alembic Secures USFDA Approval for Tretinoin Acne Cream
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Alembic Pharmaceuticals receives USFDA final approval for its generic Tretinoin cream USP, 0.05%, for acne treatment. Market size estimated at $76M.
New Delhi, Jun 12 (PTI) Drug firm Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for its generic version of Tretinoin cream used in acne treatment.
The company has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Tretinoin cream USP, 0.05 per cent, Alembic Pharmaceuticals said in a regulatory filing.
"It has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) Tretinoin cream USP, 0.05 per cent," it said.
The approved product is 'therapeutically equivalent' to Bausch Health US LLC's reference listed drug (RLD) Retin-A Cream, 0.05 per cent, it added.
Tretinoin cream is indicated for topical application in the treatment of acne vulgaris.
According to IQVIA data, the product has an estimated market size of USD 76 million for the 12-month period ended March 2026.
The company has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Tretinoin cream USP, 0.05 per cent, Alembic Pharmaceuticals said in a regulatory filing.
"It has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) Tretinoin cream USP, 0.05 per cent," it said.
The approved product is 'therapeutically equivalent' to Bausch Health US LLC's reference listed drug (RLD) Retin-A Cream, 0.05 per cent, it added.
Tretinoin cream is indicated for topical application in the treatment of acne vulgaris.
According to IQVIA data, the product has an estimated market size of USD 76 million for the 12-month period ended March 2026.
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