Blood pressure generics to be included in FDA’s testing plans

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Blood pressure generics to be included in FDA’s testing plans

Generics/News | Posted 16/05/2014 0 Post your comment

The US Food and Drug Administration (FDA) is planning an extensive study of blood-pressure drugs after receiving thousands of complaints from doctors and patients.

FDA has been allocated US$20 million for testing generics, with the 2014 focus being on heart drugs, attention deficit hyperactivity disorder (ADHD) treatments, immunosuppressants, anti-seizure medicines and antidepressants [1]. But due to the high number of complaints – more than 3,400 adverse reaction reports citing lack of effectiveness and side effects – FDA has expanded this to include the high blood pressure treatment metoprolol succinate.

The drugs to be tested are generics of AstraZeneca’s extended release Toprol XL (metoprolol succinate). They include generics produced by US-based generics makers Actavis and Mylan, as well as India-based generics makers Dr Reddy’s Laboratories and Wockhardt.

The existing testing programme includes 19 studies on generics. Some of the research is expected to be completed in September 2014, while other studies may take several years to complete, the agency has said.

The research into metoprolol succinate will begin in September 2014 and can last as long as three years, according to FDA.

Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA starts widespread testing of generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 16]. Available from: www.gabionline.net/Generics/General/FDA-starts-widespread-testing-of-generics

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Source: Bloomberg