Alembic Pharma gets USFDA nod for infection treatment drug
- IBEF
- January 29, 2020
Alembic Pharmaceuticals, a drug firm, has received a final nod from the US health regulator for Azithromycin tablets, that are used for the treatment of infections.
According to the drug firm's filing to BSE, "Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Azithromycin Tablets USP, 600 mg".
Azithromycin tablet is a macrolide antibacterial drug used in the treatment for mild to moderate infections.
The filing added that the approved ANDA is a therapeutically equivalent variant of the reference listed drug product Zithromax tablets, 600 mg, of Pfizer.
According to the IQVIA, the estimated market size for Azithromycin tablets USP, 600 mg is US$ 2 million for 12 months ending September 2019.
Till now, Alembic Pharmaceuticals has a cumulative total of 115 ANDA approvals (103 final approvals and 12 tentative approvals) from USFDA.
The shares of the company were trading at Rs 628.35 (US$ 8.99) a piece on BSE in morning, up 2.20 per cent from the previous close.
Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.
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