In a major boost to some Indian drug makers, the US Food and Drug Administration (US FDA) has approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used treat depression and other conditions. According to a US FDA press release, Aurobindo Pharma, Dr Reddy’s Laboratories, Lupin, Sun Pharma Global FZE, and Torrent Pharmaceuticals have received the regulatory nod to market duloxetine in various strengths, besides Teva Pharmaceuticals, US.
Cymblta garnered $ 1.1 billion revenues for the quarter ended September 30, 2013 and $ 3.4 billion for the nine months period in the US market, according to a report by Eli Lilly. Eli Lilly in the Q3 results statement said, “The company would lose effective exclusivity for Cymbalta in the US on December 11, 2013 and several manufacturers have received tentative approvals to market generic duloxetine.” Kathleen Uhl, Managing Director and Acting Director of the Office of Generic Drugs in the FDA’s Centre for Drug Evaluation and Research, said healthcare professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards. Generic drugs offer greater access to healthcare for many people. Duloxetine and other anti-depressant drugs have a boxed warning describing the increased risk of suicidal thinking and behaviour during initial treatment in children, adolescents, and young adults aged 18 to 24.
EP New Bureau – Mumbai