Shares of Zydus Lifesciences Ltd. ended higher on Thursday after the company received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Indomethacin suppositories, which is used to treat arthritis.
In addition, the company has been given a Competitive Generic Therapy (CGT) designation by the USFDA for its Indomethacin suppositories.
Besides, the pharma company has been granted 180-day CGT exclusivity to market this product.
In a filing to the stock exchanges, Zydus Lifesciences said that it has obtained the clearance to manufacture Indomethacin suppositories in the strength of 50 mg, which is the generic version of Indocin suppositories.
Indomethacin suppositories is used for treatment of moderate to severe rheumatoid arthritis including acute flares of chronic disease, moderate to severe ankylosing spondylitis, moderate to severe osteoarthritis and acute gouty arthritis.
As per the filing, Indomethacin suppositories had annual sales of about $95 million in the United States, as per IQVIA MAT April 2023 data.
“We are happy to leverage the CGT approval pathway of the USFDA to provide patients with expanded access to a product with limited competition,” Sharvil Patel, Managing Director, Zydus Lifesciences, said.
Last month, the USFDA closed the inspection at Zydus Lifesciences’ Ahmedabad unit with voluntary action indicated’ (VAI) recommendation in the Establishment Inspection Report’ (EIR). The US drug regulator conducted an inspection at the unit between March 20 and March 24, 2023.
Before this, Zydus received tentative approval from the USFDA for palbociclib tablets, which are used in the treatment of a certain type of breast cancer.
Shares of Zydus Lifescienes ended 1.8 percent higher at Rs 640.10.
