Alembic Global Holdings SA has received tentative approval from the US
Food and Drug Administration for its abbreviated new drug application
(ANDA) Treprostinil Injection in the strengths of 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 Pharmaceuticals said in a
regulatory filing.
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/alembic-pharma-arm-gets-tentative-usfda-nod-for-drug-to-treat-pulmonary-arterial-hypertension/articleshow/77972436.cms
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