NEW DELHI, Jan 28: Drug firm Alembic Pharmaceuticals on Tuesday said it has received a final nod from the US health regulator for Azithromycin tablets, used for the treatment of infections.
“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,” the drug firm said in a filing to BSE.
Azithromycin tablet is a macrolide antibacterial drug indicated for mild to moderate infections.
The approved ANDA is therapeutically equivalent to the reference listed drug product Zithromax tablets, 600 mg, of Pfizer, the filing said.
Citing IQVIA, the company said Azithromycin tablets USP, 600 mg have an estimated market size of USD 2 million for 12 months ending September 2019.
Alembic Pharmaceuticals has a cumulative total of 115 ANDA approvals (103 final approvals and 12 tentative approvals) from USFDA.