Corporate News     03-Aug-23
Zydus receives USFDA approval for Indomethacin suppositories
Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Indomethacin suppositories, 50mg. Zydus' Indomethacin suppositories, 50 mg is the generic version of the Reference Listed Drug (RLD) IndocinĀ® suppositories. Zydus has been granted a CGT designation by the USFDA for its Indomethacin suppositories. Zydus' Indomethacin suppositories also been granted 180-day CGT exclusivity to market this product.

Indomethacin suppositories is a non-steroidal, anti-inflammatory drug indicated for moderate to severe rheumatoid arthritis including acute flares of chronic disease, moderate to severe ankylosing spondylitis, moderate to severe osteoarthritis, acute painful shoulder (bursitis and/or tendinitis) and acute gouty arthritis. Indomethacin suppositories 50mg had an annual sales of approximately USD 95 mn in the United States (IQVIA MAT April-2023).

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