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Alembic Pharmaceuticals announced it 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, LLC (Allergan).
Asenapine is an atypical antipsychotic indicated for bipolar I disorder as adjunctive therapy to lithium or valproate in adults.
Alembic had previously received tentative approval for this ANDA. 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 US$ 217 million for twelve months ending September 2020 based on IQVIA.
