Latest News | Alembic Pharma Arm Receives Final USFDA Approval for Generic Fever Blisters Drug
Get latest articles and stories on Latest News at LatestLY. 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.
New Delhi, May 4 (PTI) 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.
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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 USD 60 million for 12 months ending December 2021.
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Alembic has received a cumulative total of 166 ANDA approvals (142 final approvals and 24 tentative approvals) from the USFDA, it added.
(The above story is verified and authored by Press Trust of India (PTI) staff. PTI, India’s premier news agency, employs more than 400 journalists and 500 stringers to cover almost every district and small town in India.. The views appearing in the above post do not reflect the opinions of LatestLY)