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In a major boost to some of the Indian drug makers, the US Food and Drug Administration has approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used in treatment of depression and other conditions.
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, USA, says a press release issued by the FDA.
Cymblta garnered USD 1.1 billion revenues for thequarter 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, MD 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.
The warning also says that the data does not show this increases the risk in those older than 24 years and that patients aged 65 and above who take anti-depressants have a decreased risk of suicidal thinking and behaviour, the FDA release added.
Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs.
Generic prescription drug manufacturing and packaging sites pass the same quality standards as those of branded drugs.