New Delhi: Drug major Sun Pharmaceutical Industries said it has received approval from the US health regulator for its INFUGEM injection used for the treatment of cancer.
This is the first US Food and Drug Administration (USFDA) approval for a product from the company’s Halol facility after receipt of Establishment Inspection Report (EIR) in June 2018, Sun Pharma said in a statement.
The approval from the USFDA is for INFUGEM injection (gemcitabine in 0.9 percent sodium chloride injection) 10 mg/mL, for intravenous use in a ready-to-administer bag, it added.
Sun Pharma, North America CEO, Abhay Gandhi said, “We’re pleased to add this novel product to our expanding oncology portfolio, as gemcitabine is one of the most commonly used cytotoxics in oncology practices.”
The technology used to formulate INFUGEM eliminates the risks associated with compounding, an extra step in the administration of cytotoxic infusion products, providing improved safety for healthcare professionals and cancer patients, he added.
As per IQVIA, “the addressable market size is approximately USD 35 million for the 12 months ending March 2018”, Sun Pharma said.
INFUGEM uses a proprietary technology which allows cytotoxic oncology products to be premixed in a sterile environment and supplied to the prescribers in RTA infusion bags, it added.