Zydus Lifesciences Ltd. on Thursday said it has received final approval from the U.S. health regulator to manufacture and market its generic Indomethacin suppositories indicated for moderate to severe rheumatoid arthritis.
The approval by the U.S. Food and Drug Administration (USFDA) is for manufacturing and marketing of Indomethacin suppositories of 50mg strength, the company said in a regulatory filing.
The company has been granted 180-day CGT (competitive generic therapy) exclusivity to market this product, it added.
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.
Zydus said 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.
Citing IQVIA MAT April 2023 data, the company said Indomethacin suppositories 50mg had annual sales of approximately $95 million in the U.S.
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