The US FDA gave approval for five Indian generic drug makers, namely Sun Pharmaceuticals Ltd., Aurobindo Pharma Ltd., Lupin Ltd., Torrent Pharmaceuticals Ltd. and Dr Reddy's Laboratories Ltd., for selling copycat version of blockbuster antidepressant Cymbalta (duloxetine delayed-release capsules), reports said.
Cymbalta is one of the most widely prescribed treatments for depression, anxiety and other disorders in the US market.
Cymbalta, the fifth largest selling drug in the world, is Eli Lilly's best-selling drug with an annual sales of $4.7 billion. The drug's patent has expired on Wednesday, causing the entry of cheaper generic versions in the US market.
Besides Indian companies, Israel-based Teva Pharmaceuticals also obtained the FDA approval.
Duloxetine and other antidepressant drugs have a boxed warning describing the increased risk of suicidal thinking and behavior during initial treatment in children, adolescents, and young adults ages 18-24, said the FDA statement.
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