American health regulators have finally given Wockhardt Ltd. permission to sell a generic version of Effexor XR, a popular but controversial SSRI antidepressant medication.
The generic version of Effexor XR is called venlafaxine hydrochloride and it will be sold in capsule form in India. Wockhardt is expected to launch the controlled released version of Effexor in the U.S. in June of this year. The American approval by the Food and Drug Administration allows Wockhardt to sell the drug in dosages of 37.5 mg, 75 mg and 150 mg.
The chairman of Wockhardt, Mr. Habil Khorakiwala, had this to say of the decision: “Our product selection strategies have revolved around maximizing our strengths in this area of pharmaceutical technology and Venlafaxine XR bears testimony to the same.”
The controlled release version of Effexor XR is manufactured by Pfizer and has been a top seller for the company in treating depression in the United States.
Recently, however, Pfizer has been subjected to various lawsuits over the side effects of Effexor. The plaintiffs all claim that the company didn’t properly warn the public about the adverse side effects associated with the drug, including aggression, excessive mood swings, suicidal thoughts and suicide. Despite the lawsuits, IMS Health says that Effexor has a global market size that is said to be as high as $2.3 billion. Wockhardt is based in Mumbai and plans to manufacturing the drug in plant at Chikalthana in Maharashtra, which is FDA-certified.
SSRI medications like Paxil and Effexor have recently been the focus of a research study that reveals the drugs can help to generate new brain cells in depressed people. While that may sound like a good thing, the risks associated with Effexor may not be worth it to many patients that opt to take the drug.