Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for Erythromycin Tablets USP, 250 mg and 500 mg, the company said via an exchange filing.
Erythromycin Tablets USP, 250 mg and 500 mg are used to prevent and treat infections in many different parts of the body, including respiratory tract infections, skin infections, diphtheria, intestinal amebiasis, acute pelvic inflammatory disease, legionnaire's disease, pertussis, and syphilis.
The drugs will be manufactured at the group’s formulation manufacturing facility in Moraiya, Ahmedabad (India).
Erythromycin Tablets USP, 250 mg and 500 mg had annual sales of USD 25.1 mn in the United States according to IQVIA MAT Dec. 2022 data.
The group now has 350 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.
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