Indian pharmaceuticals manufacturer Wockhardt said it received approval from the United States Food & Drug Administration to launch a generic version of Novartis’ Leukemia drug Gleevec.
The drug is estimated to have sales of $707 million in the US.
The Indian company, which already has many of its products on US pharmacy shelves, said it will launch the product in the United States “in a short period of time”.
The approval is for 100mg and 400mg tablets of Imatinib Mesylate, the molecular name of the drug.
“Imatinib stops the cancer cells from growing and is indicated for treating cancers like Leukemia and some Gastro-lntestinal tumors,” Wockhardt said.
The drug is being manufactured at a contract manufacturing facility based near Hyderabad, it added.
Dr. Habil Khorakiwala, Founder Chairman and Group CEO, said Wockhardt is building a portfolio of oncology products in the US and has several pending approvals for generic cancer drugs in the country.
“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.
Headquartered in Mumbai, the company has manufacturing plants in India, UK, Ireland, France and US, and subsidiaries in US, UK, Ireland and France.
Founded around 50 years ago, Wockhardt is the first company outside the US and Europe to manufacture recombinant human insulin.