Wockhardt Gets U.S. FDA Nod For Generic Cancer Drug
Wockhardt receives U.S. FDA approval for generic version of Gleevec used for the treatment of cancer and tumours.
Wockhardt Ltd. said it received approval from the U.S. health regulator for generic version of Gleevec used for the treatment of cancer and tumours.
“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,” the company said in a BSE filing.
Its Imatinib Mesylate tablets are a generic version of Gleevec, marketed in the U.S. and other countries by Novartis.
“Wockhardt is building a portfolio of oncology products in the U.S. and has several pending ANDA’s for oncology products,” Habil Khorakiwala, founder chairman and group chief executive officer of Wockhardt, said.
Oncology and other specialty products have always been a priority area for our U.S. business and this product will further boost this focus, he said.
The product is being manufactured at a contract manufacturing facility, based near Hyderabad, the drugmaker said.
Shares of Wockhardt were trading 1.3 percent higher as of 11:08 a.m.