Zydus receives Final Approval from the USFDA for Indomethacin Suppository with Competitive Generic Therapy designation

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as "Zydus") has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Indomethacin suppositories, 50mg. Zydus' Indomethacin suppositories, 50 mg is the generic version of the Reference Listed Drug (RLD) Indocin® suppositories. Zydus has been granted a CGT designation by the USFDA for its Indomethacin suppositories. Zydus' Indomethacin suppositories also been granted 180-day CGT exclusivity to market this product.

"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 Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Limited. He further added, "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."

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. Indomethacin suppositories 50mg had an annual sales of approximately USD 95 mn in the United States (IQVIA MAT April-2023).

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 628.10 as compared to the previous close of Rs. 633.95. The total number of shares traded during the day was 33106 in over 2695 trades.

The stock hit an intraday high of Rs. 635.10 and intraday low of 622.00. The net turnover during the day was Rs. 20784752.00.

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 USFDA FinalApproval Indomethacin Suppositories