Drug firm Alembic Pharmaceuticals on Friday said its arm, Alembic Global Holding SA, has received approval from the US health regulator for its generic Treprostinil injection used for the treatment of pulmonary arterial hypertension.
“Alembic Global Holding SA has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for 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,” Alembic Pharma said in a regulatory filing.
The product is a generic version of United Therapeutics Corp Remodulin injection in the same strengths, it added. Treprostinil injection has an estimated market size of USD 17 million for twelve months ending December 2020, Alembic Pharma said.
The injection is indicated for the treatment of pulmonary arterial hypertension (PAH) 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, it added.
The company has a total of 138 ANDA approvals (121 final approvals and 17 tentative approvals) from USFDA, the filing said. Shares of Alembic Pharmaceuticals were trading at Rs 967.00 per scrip on the BSE, up 3.47 per cent from its previous close.