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Wockhardt gets USFDA nod for Decitabine injection

Press Trust of India  |  New Delhi 

Pharma Wednesday said it has received approval from the US health regulator for its 50 mg injection of which is used to treat certain forms of

"has received approval from the Food and Drug Administration (USFDA) for an ANDA (abbreviated new drug application) for 50 mg injection of Decitabine, which is used to treat certain forms of cancer," the company said in a filing to the BSE.

is used to treat (MDS) -- a group of in which immature blood cells in the bone marrow do not mature and, therefore, do not become healthy blood cells.

According to IQVIA data, the product has sales of USD 120 million in the US.

"This is the third USFDA approval for an for during the past three months, and has added to our growing portfolio of drugs," said.

"Wockhardt has been sustaining growth in the US and worldwide through an increasing portfolio of specialty products including oncology drugs," he said.

Wockhardt will launch this product in the US in a short period of time.

With its nationwide and its relationship with all trade, retail and institutional customers, Wockhardt is already a significant pharmaceutical market, the company said.

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

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Wed, April 10 2019. 21:30 IST
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