Alembic Pharma JV gets USFDA approval for Desonide Ointment to treat skin diseases

Desonide Ointment, 0.05 per cent, is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, Alembic Pharmaceuticals said in a BSE filing.

New Delhi: Drug firm Alembic Pharmaceuticals on Thursday said it's joint venture firm Aleor Dermaceuticals has got approval from the US health regulator for Desonide Ointment. Desonide Ointment, 0.05 per cent, is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, Alembic Pharmaceuticals said in a BSE filing.

The company said its joint venture Aleor Dermaceuticals has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Desonide ointment 0.05 per cent.

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Citing IQVIA data, the company said the approved ANDA is therapeutically equivalent to the reference listed drug product, Desonide Ointment, 0.05, of Perrigo New York, Inc. It has an estimated market size of USD 13 million for 12 months ending December 2018.

Alembic has a cumulative total of 105 ANDA approvals (93 final approvals and 12 tentative approvals) from the USFDA.

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