Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Indomethacin suppositories, 50mg, the company announced through an exchange filing. 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 have 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, Managing Director, Zydus Lifesciences Limited. He further added, “The achievements of our team who have worked on the development, filing and manufacturing of Indomethacin suppositories reflects our ongoing commitment to bring complex generic products accessible to patients who need them the most.”
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).
