Zydus Lifesciences gets USFDA’s final nod for Metronidazole Topical Cream

The USFDA has given Zydus Lifesciences the go-ahead to produce and sell Metronidazole Topical Cream, 0.75% (USRLD: MetroCream, 0.75%). An antibiotic called metronidazole is applied to the skin to treat rosacea, a form of adult acne. It is anticipated to aid in reducing redness, swelling, and the quantity of pimples brought on by rosacea, and is thought to function by reducing swelling (inflammation). The group’s topical manufacturing facility in Changodar, Ahmedabad (India), will produce the medication. In the United States, metronidazole topical cream, 0.75% had annual sales of $25 million (IQVIA MAT February 2023). Since the filing process began in FY 2003–2004, the group has received 366 approvals and has submitted over 440 ANDAs.

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