Zydus Lifesciences gains on USFDA nod to arthritis drug

Zydus Lifesciences has received final approval from the USFDA to manufacture and market Indomethacin suppositories

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Zydus Lifesciences share price rose nearly 3 percent to Rs 644.90 in the in morning trade on August 3 after the company received the United States Food and Drug Administration (USFDA) nod for its arthritis drug.

Zydus Lifesciences has received final approval from the USFDA to manufacture and market Indomethacin suppositories 50mg.

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

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“We are happy to leverage the CGT approval pathway of the USFDA to provide patients with expanded access to a product with limited competition,” said Sharvil Patel, Managing Director, Zydus Lifesciences Limited.

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.

The company’s board will meet on August 11 to consider, apart from other agenda items, approval of unaudited financial results for the quarter ended on June 30, 2023.

On July 27, the company received final approval from the USFDA for Plerixafor injection.