Instant Report

Date: 21-Apr-2020

Alembic Pharma Gets US FDA Approval For Lastacaft Ophthalmic Solution

Alembic Pharmaceuticals Limited has received tentative approval from the US Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) alcaftadine ophthalmic solution, 0.25%.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Lastacaft ophthalmic solution, 0.25%, of Allergan, Inc.

Alcaftadine ophthalmic solution is an H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis.

Alcaftadine ophthalmic solution, 0.25% has an estimated market size of US$ 7 million for twelve months ending December 2019, according to IQVIA.

Alembic has a cumulative total of 120 ANDA approvals (107 final approvals and 13 tentative approvals) from US FDA

Date: 13-Feb-2021

Alembic Pharma Gets US FDA Approval For Generic Remodulin Injection

Alembic Pharmaceuticals Limited announced that its wholly-owned subsidiary Alembic Global Holding SA has received final approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) treprostinil injection, 20 mg/20 mL (1 mg/mL), 50 mg/20 mL (2.5 mg/mL), 100 mg/20 mL (5 mg/mL), and 200 mg/20 mL (10 mg/mL), multiple-dose vials.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Remodulin injection, 20 mg/20 mL (1mg/mL), 50 mg/20 mL (2.5 mg/mL), 100 mg/20 mL (5 mg/mL), and 200 mg/20 mL (10mg/mL), of United Therapeutics Corp.

Treprostinil injection is indicated for the treatment of pulmonary arterial to diminish symptoms associated with exercise.

In patients with PAH requiring transition from epoprostenol, treprostinil injection is indicated to diminish the rate of clinical deterioration. Alembic had previously received tentative approval for this ANDA.

Treprostinil injection has an estimated market size of US$ 17 million for twelve months ending December 2020, according to IQVIA.

Alembic now has a total of 138 ANDA approvals (121 final approvals and 17 tentative approvals) from US FDA, including this first injectable ANDA approval.