Alembic obtains 2 FDA approvals, 1 tentative

Alembic has received two approvals from the Food and Drug Administration, one of them tentative. Alembic got full approval for its generic of DesOwen lotion (desonide lotion 0.05%) via its Aleor Dermaceuticals joint venture, and tentative approval for its generic of Boehringer Ingelheim's Glyxambi (empagliflozin and linagliptin) tablets. 

Desonide lotion is indicated to treat inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. It had an annual market value of $7 million for the 12 months ended June 2020, according to IQVIA.

Alembic's Glymbaxi generic was granted tentative approval in dosage strengths of 10 mg/5 mg and 25 mg/5 mg. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes when treatment with both empagliflozin and linagliptin is appropriate.

Empagliflozin and linagliptin tablets, 10 mg/5 mg and 25 mg/5 mg, had a market value of $244 million for the 12 months ending June 2020, according to IQVIA.

Alembic currently is in litigation with Boehringer in the District Court of Delaware, and the launch of the product will depend on the outcome of litigation, the company said.