Sun
Pharmaceutical Industries 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 the receipt of Establishment Inspection Report
(EIR) in June 2018, Sun Pharma said in a statement today.
The USFDA
approval is for INFUGEM injection (gemcitabine in 0.9 per cent sodium chloride
injection) 10 mg/mL, for intravenous use in a ready-to-administer bag.
Sun Pharma’s
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 $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.
Sun Pharma
shares were trading down by 0.26 per cent at Rs 547.35 on the BSE.
www.thehindubusinessline.com/companies/sun-pharma-gets-usfda-nod-for-cancer-injection/article24450679.ece
