Zydus Lifesciences gains USFDA approval for arthritis medication

3 Aug 2023 , 02:48 AM

The morning trade on August 3 saw a roughly 3% increase in the share price of Zydus Lifesciences to Rs 644.90 after the firm gained approval from the US Food and Drug Administration (USFDA) for its arthritis medication.

The USFDA has given Zydus Lifesciences the go-ahead to produce and sell 50mg of Indomethacin suppositories.

The generic form of the reference listed drug (RLD) Indocin suppositories is called indomethacin. The FDA granted a Competitive Generic Therapy (CGT) designation and a 180-day CGT exclusivity to market the medication.

According to Sharvil Patel, Managing Director of Zydus Lifesciences Limited, ‘We are happy to use the CGT approval pathway of the USFDA to provide patients with expanded access to a product with little competition.’

Ankylosing spondylitis, osteoarthritis, bursitis and/or tendinitis of the shoulder, acute gouty arthritis, and moderate to severe rheumatoid arthritis are all conditions for which indomethacin suppositories are prescribed. They also include acute flare-ups of chronic disease.

On August 11, the company’s board of directors will meet to discuss, among other things, whether to approve the unaudited financial results for the quarter that ended on June 30, 2023.

The USFDA gave the company final approval for Plerixafor injectable on July 27.

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