Wockhardt Ltd. announced that the drugmaker has received approval from the U.S. health regulator, USFDA, for the generic version of Gleevec used for the treatment of cancer and tumours.
The pharmaceutical company in its BSE filing said, “Wockhardt has received approval from the U.S. Food & Drug Administration for an abbreviated new drug application for 100 mg and 400 mg tablets of Imatinib Mesylate.” Imatinib Mesylate tablets are a generic version of Gleevec, marketed in the U.S. and other countries by Novartis.
Habil Khorakiwala, Founder Chairman and group CEO (chief executive officer) said: “Wockhardt is building a portfolio of oncology products in the U.S. and has several pending ANDA’s for oncology products.”
He added that the number one priority area for the company’s U.S. business has always been oncology and other speciality products and the approved product will further boost this focus. The pharma company said that the product is being manufactured at a contract manufacturing facility, based near Hyderabad.