The approved ANDA is therapeutically equivalent to the reference listed drug product Abreva Cream, 10 per cent (OTC) of GlaxoSmithKline Consumer Healthcare, the company said.
PTI
May 04, 2022 / 12:06 PM IST
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Alembic Pharmaceuticals on Wednesday said its wholly-owned arm Aleor Dermaceuticals has received final approval from the US health regulator for its generic Docosanol cream indicated for cold sore/fever blisters on the face or lips.
The final approval granted by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Docosanol cream, 10 per cent (over the counter), the company said in a regulatory filing.
The approved ANDA is therapeutically equivalent to the reference listed drug product Abreva Cream, 10 per cent (OTC) of GlaxoSmithKline Consumer Healthcare, it added.
Citing IQVIA data, Alembic said Docosanol cream, 10 per cent (OTC) has an estimated market size of $ 60 million for 12 months ending December 2021.
Alembic has received a cumulative total of 166 ANDA approvals (142 final approvals and 24 tentative approvals) from the USFDA, it added.
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