Mumbai: Pharma company Wockhardt on Wednesday said
it has received the final approval from the US drug regulator
for its anti-hypertensive injection Nicardipine.
The US Food and Drug Administration (FDA) has given final
approval for marketing of Nicardipine HCI injections in
25mg/10 ml strength, used in the treatment of hypertension,
Wockhardt Ltd said in a filing to the Bombay Stock Exchange.
Nicardipine is the generic name for Cardene, patented by
the US-based drug firm EKR Therapeutics. This patent expired
yesterday.
Wockhardt is launching the product immediately in the US
market, the filing added.
"This is our seventeenth sterile product approval in the
US, based on a variety of technologies like liquid injections
in vials and pre-filled syringes, powder for injection and
opthalmic solutions," Wockhardt Chairman Habil Khorakiwala
said.
According to industry research firm IMS, the total market
for Nicardipine injection in the US is more than USD 200
million.
The company would manufacture these injections at its
US FDA-certified formulation plant at Waluj, Aurangabad.
Shares of Wockhardt today closed at Rs 180.35, down 1.53
per cent from previous close on the BSE.
Bureau Report
First Published: Wednesday, November 18, 2009, 18:08