|Wockhardt's Chikalthana plant--Courtesy of Wockhardt|
India's Wockhardt has faced tough sanctions from the FDA in the last year, with the agency banning products from two of its plants in India. But the company still has other facilities that can serve the U.S. and is recalling a product made at one of those, the same product that the FDA is currently testing over questions of effectiveness and side effects.
According to the FDA's most recent Enforcement Report, Wockhardt is voluntarily recalling nearly 110,000 bottles of 50 mg metoprolol succinate extended release, its generic version of the AstraZeneca ($AZN) hypertension drug Toprol XL. The notice said the drug is made at a Wockhardt facility in Mumbai and that it failed its 9-month dissolution specification test.
The FDA last year launched a $20 million program to test some generic drugs for equivalency. The agency earlier this month said it is currently testing metoprolol succinate, a drug that accounts for about 40 million prescriptions a year, 90% of which are generics of AstraZeneca's Toprol XL. Wockhardt is one of four producers of the product, along with Mylan ($MYL), Actavis ($ACT) and Dr. Reddy's Laboratories. Bloomberg ran an analysis of adverse effects reports and found the generics accounted for more than 3,400 adverse reaction reports over effectiveness and side effects.
Spokeswoman Sandy Walsh earlier this month said the FDA has already conducted tests to see if the generics dissolve properly and now wants more extensive studies. She said the FDA has also rethought the criteria that were used for approval of the generics. According to an FDA grant request, it wants researchers to conduct "pharmacokinetic and pharmacodynamic (PK-PD)" studies of metoprolol succinate.
Generics make up about 80% of the prescriptions written in the U.S., and because India produces about 40% of the generics used in this country, the question of generic effectiveness has melded with concerns over the quality standards of some drugmakers. The FDA in the last year has banned Wockhardt plants in Chikalthana, as well as a Wockhardt plant in Waluj, India. The plant in Chikalthana also reportedly made metoprolol succinate for the U.S. market before it was banned. An FDA warning letter for the two plants cited them for unsanitary conditions and for manipulating the results of quality tests.
- here's the enforcement report