FDA grants competitive generic therapy approval for indomethacin suppositories
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The FDA has granted final approval to Zydus Lifesciences to manufacture and market generic indomethacin 50 mg suppositories, according to a company press release.
“We are happy to leverage the [competitive generic therapy (CGT)] approval pathway of the USFDA to provide patients with expanded access to a product with limited competition,” Sharvil Patel, PhD, managing director of Zydus Lifesciences Limited, said in the release. “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.”
The approval gives Zydus the ability to manufacture and market the drug, a generic version of Indocin (indomethacin, Iroko Pharmaceuticals) suppositories, in the United States. In addition, the company has been granted 180 days of competitive generic therapy exclusivity for marketing, the release said.
Indomethacin, a non-steroidal, anti-inflammatory therapy, is indicated for moderate to severe rheumatoid arthritis, including acute flares of chronic disease, as well as moderate to severe ankylosing spondylitis, moderate to severe osteoarthritis, acute painful shoulder — bursitis and/or tendinitis — and acute gouty arthritis.
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