FDA gives Alembic tentative nod for generic Remodulin
The Food and Drug Administration has granted tentative approval to Alembic its generic Remodulin (trpostinil for injection). The drug is indicated to treat pulmonary arterial hypertension symptoms associated with exercise.
Alembic's generic was approved in three dosage strengths: 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), all in multiple-dose vials.
Alembic said the brand had a market value of roughly $466.1 million for the 12 months ended December 2019, according to United Therapeutics’ 2019 financial results.