New Delhi, Jan 21 (PTI) Drug firm Wockhardt Monday said it has received approval from the US health regulator for generic version of Gleevec used for treatment of cancers and tumours.
Wockhardt has received approval from the United States Food & Drug Administration (USFDA) for an abbreviated new drug application (ANDA) for 100 mg and 400 mg tablets of Imatinib Mesylate, the company said in a BSE filing.
Wockhardt’s Imatinib Mesylate tablets are a generic version of Gleevec, marketed in USA and other countries by Novartis.
“Wockhardt is building a portfolio of oncology products in the US and has several pending ANDA’s for oncology products,” Wockhardt Founder Chairman and Group CEO Habil Khorakiwala said.
Oncology and other specialty products have always been a priority area for our US business and this product will further boost this focus, he added.
Wockhardt said it will launch this product in the United States, in a short period of time.
The product is being manufactured at a contract manufacturing facility, based near Hyderabad, the company added.
Shares of Wockhardt were trading 1.74 per cent higher at Rs 498 apiece on BSE.
This is published unedited from the PTI feed.