Categories: US FDA Approval

Wockhardt Receives US FDA Approval for cancer drug

Mumbai, April 24, 2019: Pharmaceutical and biotechnology major Wockhardt has received approval from the United States Food & Drug Administration (US FDA) for an ANDA for 50mg injection of Decitabine, which is used to treat certain forms of cancer. Wockhardt’s Decitabine Injection is a generic version of Dacogen®, marketed in USA and other countries by Otsuka.

Decitabine is used to treat Myelodysplastic syndromes (MDS), a group of cancers in which immature blood cells in the bone marrow do not mature and therefore do not become healthy blood cells. According to IQVIA February 2019 data, the product has sales of $120 million in the US.

“This is the third US FDA approval for an oncology product for Wockhardt during the past three months, and has added to our growing portfolio of cancer drugs” said Dr. Habil Khorakiwala, Founder Chairman, Wockhardt Group. “Wockhardt has been sustaining growth in the US and worldwide through an increasing

portfolio of specialty products including oncology drugs” 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.

The product is being manufactured at a contract manufacturing facility, based near Hyderabad, India.

Corporate Comm India(CCI Newswire)

The Pharma Times News Bureau

Recent Posts

Bayer Introduces Bepanthen in India as New Survey Reveals Dry Skin Affects 1 in 2 Indians

·        World's no.1 skincare brand Bepanthen* launches in India, as a solution to tackle India's widespread dry skin…

8 hours ago

Lung Cancer in India: Understanding Risk Factors and the Importance of Early Detection

By Dr. Pavan Yadav, Lead Consultant - Interventional Pulmonology & Lung Transplantation, Aster RV Hospital.…

1 day ago

10 Winter Skin Care Tips Dermatologists Swear By

Dr. Priyanka Kuri, Consultant - Dermatology, Aster Whitefield Hospital, Bengaluru  Winter weather brings a host…

4 days ago

Fighting Viral Hepatitis in India: Prevention, Risks, and the Path to Better Health

By Dr. Naveen Ganjoo, Senior Consultant - Hepatology & Integrated Liver Care, Aster RV Hospital…

5 days ago

Hon’ble Prime Minister Shri Narendra Modi Inaugurates LyfiusPharma’s Flagship Penicillin-G Facility at Kakinada, Andhra Pradesh

Under the Production Linked Incentive(PLI)scheme, Lyfius Pharma Private Limited(LyfiusPharma) invested ₹2,500 crores in Penicillin-G( Pen-G)facility…

6 days ago