Zydus Lifesciences Gets USFDA Approval for Generic Rheumatoid Arthritis Treatment Drug

Later this week, Zydus Lifesciences Ltd announced that it has gained final permission from the US Food and Drug Administration to manufacture and market its generic Indomethacin suppositories for moderate to severe rheumatoid arthritis. The US Food and Drug Administration (USFDA) approved the company to manufacture and commercialise Indomethacin suppositories with a 50mg strength, according to a regulatory filing.

According to the firm, it has been awarded 180-day CGT (competitive generic treatment) exclusivity to promote this medicine. As per the USFDA, it may designate a drug as a CGT after determining that there is inadequate generic competition for that drug. "We are happy to leverage the CGT approval pathway of the USFDA to provide patients with expanded access to a product with limited competition," Zydus Lifesciences Managing Director Dr Sharvil Patel said.

Indomethacin suppositories are a nonsteroidal 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, according to Zydus. According to IQVIA MAT April 2023 statistics, Indomethacin suppositories 50mg had yearly sales of around USD 95 million in the United States.