Wockhardt gets USFDA nod for generic Imatinib Mesylate tablets

Wockhardt's Imatinib Mesylate tablets are a generic version of Gleevec, marketed in the USA and other countries by Novartis.

Mumbai: Drug firm Wockhardt on Monday said it has received approval from the US health regulator for a generic version of Gleevec used for the 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 the 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.

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.

Wockhardt Ltd. is a global pharmaceutical and biotechnology company headquartered in Mumbai, India. The company has manufacturing plants in India, UK, Ireland, France and US, and subsidiaries in the US, UK, Ireland and France.

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