Wockhardt's generic version of Pfizer's Effexor XR capsules gets US FDA approval
19 April 2011
Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 37.5mg, 75mg and 150mg extended release capsules of Venlafaxine HCl, which is used for treatment of depression and anxiety disorders.
Venlafaxine is the generic equivalent of Pfizer's Effexor XR, which is marketed in the US. Wockhardt said it plans to start marketing the product in the US market from 1 June 2011.
Pfizer's Effexor XR has a total market of about $2.3 billion in the US and is one the most widely used antidepressant drugs.
The product is a capsule containing specially designed pellets to extend their release over 24 hours and requires specialised technology and manufacturing capability.
"This is yet another successful demonstration of our capabilities in developing and manufacturing products based on extended-release technologies", Wockhardt chairman Habil Khorakiwala said.
"Our product selection strategies have revolved around maximising our strengths in this area of pharmaceutical technology and Venlafaxine XR bears testimony to the same," he added.