Alembic gets USFDA approval for Asenapine Sublingual Tablets

Asenapine is an atypical antipsychotic indicated for bipolar I disorder

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USFDA
Picture: Pixabay

Last Updated on December 13, 2020 by The Health Master

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Asenapine Sublingual Tablets, 5 mg and 10 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Saphris Sublingual Tablets, 5 mg and 10 mg, of Allergan Sales.

Asenapine is an atypical antipsychotic indicated for bipolar I disorder as adjunctive treatment to lithium or valproate in adults. Alembic had previously received tentative approval for this ANDA.


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Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification and hence is eligible for 180 days of shared exclusivity

Asenapine Sublingual Tablets, 5 mg and 10 mg have an estimated market size of $217 million for twelve months ending September 2020 according to IQVIA.

Alembic has a cumulative total of 137 ANDA approvals (119 final approvals and 18 tentative approvals) from USFDA.


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