Latest News | Alembic Gets USFDA Nod for Generic Skin Treatment Cream
Get latest articles and stories on Latest News at LatestLY. Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator to market Desonide Cream used in treating skin conditions with inflammation and itching in the American market.
New Delhi, Dec 9 (PTI) Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator to market Desonide Cream used in treating skin conditions with inflammation and itching in the American market.
The company said it has received the final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Desonide Cream, 0.05 per cent.
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The ANDA was filed by Aleor Dermaceuticals (Aleor), which was amalgamated with Alembic, the drug firm said in a statement.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Desonide Cream, 0.05 per cent, of Padagis US LLC.
Desonide Cream, 0.05 per cent, is a low-potency corticosteroid indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
According to IQVIA, Desonide Cream, 0.05 per cent, has an estimated market size of USD 12 million for twelve months ending September 2022.
Alembic said it has now received a cumulative total of 178 ANDA approvals (155 final approvals and 23 tentative approvals) from the USFDA.
(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)