Wockhardt Receives US FDA Approval for Leukemia drug
Deepthi | Myequity news | Date : 21-01-2019 09:35:00 IST
Pharmaceutical and biotechnology major Wockhardt has received approval from the United States Food & Drug Administration (US FDA) for an ANDA for 100mg and 400mg 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. The product is being manufactured at a contract manufacturing facility, based near Hyderabad, India.
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. About Wockhardt:
"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 is a Global Pharmaceutical and Biotech company with presence in USA, UK, Ireland, Switzerland, France, Mexico, Russia and many other countries. It has manufacturing and research facilities in India, USA & UK and a manufacturing facility in Ireland. Wockhardt has a significant presence in USA, Europe and India, with 60% of its global revenues coming from international businesses. Wockhardt is the only company in the world where USFDA has given Q.IDP Status (Qualified Infectious Diseases Programme) for 5 of our Anti-bacterial discovery programmes - 2 of them are Gram Negative and 3 Gram Positive effective against untreatable "Superbugs". Wockhardt's entire Anti-infective portfolio particularly addresses the specific bacterial organism where resistances are high and breakthrough antibiotics are needed.