Alembic Pharmaceuticals announces USFDA Final Approval for Asenapine Sublingual Tablets, 5 mg and 10 mg

Alembic Pharmaceuticals Limited (Alembic) today 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 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.

Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.1060.3 as compared to the previous close of Rs. 1054.2. The total number of shares traded during the day was 22898 in over 2029 trades.

The stock hit an intraday high of Rs. 1070.95 and intraday low of 1025.9. The net turnover during the day was Rs. 24111268.

Source : Equity Bulls

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