Zydus gets USFDA approval for Indomethacin suppository with CGT designation

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) Indocin 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.

“We are happy to leverage the CGT approval pathway of the USFDA to provide patients with expanded access to a product with limited competition,” said Dr Sharvil Patel, MD, Zydus Lifesciences.

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 annual sales of approximately $95 million in the US (IQVIA MAT April-2023).