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Alembic Pharma gets USFDA nod for Asenapine Sublingual Tablets to treat bipolar disorder
Asenapine is an atypical antipsychotic indicated for bipolar I disorder as adjunctive treatment to lithium or valproate in adults.
Vadodara: Drugmaker, Alembic Pharmaceuticals Limited, has recently announced that the company 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 treatment 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 according to IQVIA. Alembic has a cumulative total of 137 ANDA approvals (119 final approvals and 18 tentative approvals) from USFDA.
Read also: Alembic Pharma Metolazone Tablets get USFDA nod
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751