Wockhardt receives US FDA approval for leukemia drug

Wockhardt received approval from the United States Food and Drug Administration (US FDA) for an ANDA for 100 mg and 400 mg tablets of Imatinib Mesylate, which is used to treat many kinds of cancers and tumors. Wockhardt’s Imatinib Mesylate tablets are a generic version of Gleevec, marketed in USA and other countries by Novartis.

Imatinib stops the cancer cells from growing and is indicated for treating cancers like Leukemia and some gastro-intestinal tumors. According to IMS MAT1118, the product has sales of $ 707 million in the US.

"Wockhardt is building a portfolio of oncology products in the US and has several pending ANDA’s for oncology products" said Dr Habil Khorakiwala, Wockhardt Founder Chairman and Group CEO. "Further, oncology and other specialty products have always been a priority area for our US business and this product will further boost this focus" he said.

Wockhardt will be launching this product in the United States, in a short period of time. With its nationwide distribution network and its excellent relationship with all major trade, retail and institutional customers, Wockhardt is already a significant player in the US pharmaceutical market.

Wockhardt’s Imatinib Mesylate tablets is being manufactured at a contract manufacturing facility, based near Hyderabad, India.

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