The US health department has given Zydus Lifesciences Ltd final license to manufacture and market its generic Indomethacin suppositories for moderate to severe rheumatoid arthritis, the company announced on Thursday. According to the company’s regulatory application, the US Food and Drug Administration (USFDA) has given its permission for the production and marketing of 50mg Indomethacin suppositories.
To promote this medicine, the company has been given a 180-day CGT (competitive generic treatment) exclusivity license, it continued.
According to the USFDA, a medicine may be designated as a CGT if it is found to have insufficient generic competition.
Zydus Lifesciences Managing Director Dr. Sharvil Patel stated, “We are happy to utilize the CGT approval pathway of the USFDA to provide patients with expanded access to a product with limited competition.”
In addition to acute flare-ups of chronic disease, moderate to severe ankylosing spondylitis, moderate to severe osteoarthritis, acutely painful shoulders (bursitis and/or tendinitis), and acute gouty arthritis are among the conditions for which Indomethacin suppositories, according to Zydus, are indicated.
The business stated that Indomethacin suppositories 50mg had annual sales of roughly USD 95 million in the US, citing IQVIA MAT April 2023 data.
Source : The Economic Times & Zydus Life.
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