Zydus Lifesciences bags USFDA nod for antibacterial drug Erythromycin

Ahmedabad: Zydus Lifesciences Limited has announced that the company has received final approval from the United States Food and Drug Administration (USFDA) for Erythromycin Tablets USP, 250 mg and 500 mg (USRLD: Erythromycin Tablets USP, 250 mg and 500 mg).

Erythromycin tablets, USP is an antibacterial product and is 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 and pertussis.

The drug will be manufactured at the group’s formulation manufacturing facility in SEZ, Ahmedabad (India).

Erythromycin Tablets USP, 250 mg and 500mg had annual sales of USD 23mn in the United States (IQVIA MAT July 2023). The group now has 379 approvals and has so far filed over 444* ANDAs since the commencement of the filing process in FY 2003-04.

Medical Dialogues team had earlier reported that the company had received final approval from the USFDA for Isotretinoin Capsules USP, 10 mg, 20 mg 30 mg and 40 mg (RLD: Accutane Capsules, 10 mg, 20 mg and 40 mg: RS: Claravis 10 mg, 20 mg, 30 mg and 40 mg).

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