Indian pharmaceutical company Alembic Pharma has received final approval from the US health regulator for its bipolar drug, the company said on Friday (December 11).
The US Food and Drug Administration (USFDA) has granted approval for its abbreviated new drug application (ANDA) for Asenapine Sublingual Tablets, the Vadodara based drug firm said in a regulatory filing.
Alembic Pharma said it was one of the first applicants to submit a substantially complete ANDA and hence is eligible for 180 days of shared exclusivity.
Quoting IQVIA data, the company said Asenapine Sublingual tablets, 5 mg and 10 mg, have an estimated market size of £164 million for one year ending September 2020.
Alembic Pharma has a cumulative total of 137 ANDA approvals including 119 final approvals and 18 tentative approvals from the American health regulator.
Asenapine is an antipsychotic drug indicated for bipolar I disorder as adjunctive treatment to lithium or valproate in adults.
