Alembic Pharma gets USFDA nod for Asenapine Sublingual Tablets by admin- Friday, December 11th, 2020 04:23:07 PM
Alembic Pharmaceuticals received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Asenapine Sublingual Tablets, five mg and 10 mg. The approved ANDA is therapeutically equal to the reference listed drug product (RLD), Saphris Sublingual Tablets, five mg and 10 mg, of Allergan Sales, LLC (Allergan). Asenapine is an ordinary antipsychotic indicated for bipolar I sickness as adjunctive treatment to lithium or valproate in adults. Alembic had formerly acquired tentative popularity of this ANDA. Alembic was one of the first ANDA applicants to submit a notably complete ANDA with a paragraph IV certification and subsequently is eligible for 180 days of shared exclusivity.
Asenapine Sublingual Tablets, five mg and 10 mg have an envisioned marketplace length of US$ 217 million for 12 months ending September 2020 according to IQVIA.
Alembic has a cumulative overall of 137 ANDA approvals (119 very last approvals and 18 tentative approvals) from USFDA.