Zydus Lifesciences gets FDA final approval for Erythromycin Tablets generic

Zydus Lifesciences said that it has secured final approval for Erythromycin Tablets USP, 250 mg and 500 mg from the US Food and Drug Administration (FDA).

The reference listed drug (RLD) of the approved product is Erythromycin Tablets.

Erythromycin Tablets USP, 250 mg and 500 mg are indicated for the prevention and treatment of infections in various parts of the body. These include respiratory tract infections, diphtheria, skin infections, acute pelvic inflammatory disease, intestinal amebiasis, pertussis, legionnaire’s disease, and syphilis.

Zydus Lifesciences gets FDA final approval for Erythromycin Tablets generic. Photo courtesy of Zydus Cadila.

Zydus Lifesciences will manufacture Erythromycin Tablets USP, 250 mg and 500 mg at its formulation manufacturing plant in Moraiya, Ahmedabad.

According to IQVIA MAT December 2022, the annual sales of Erythromycin Tablets USP, 250 mg and 500 mg in the US is $25.1 million.