FDA approves Solco Healthcare’s Cymbalta generic
SILVER SPRING, Md. — The Food and Drug Administration has approved Solco Healthcare’s generic of Cymbalta (duloxetine) delayed-release capsules, the company recently announced.
The drug is indicated to treat major depressive disorder in adults, as well as general anxiety disorder in adults and children ages 7 years and older. It also can be used to treat fibromyalgia or chronic muscle or joint pain.
“We are pleased to receive this FDA approval, which adds to our growing line of central nervous system acting agents,” Solco Healthcare president Hai Wang said. “We continue to strengthen our presence within the U.S. generic market by providing high-quality medicines at affordable prices.”
The company said its generic is available now in 20-, 30- and 60-mg dosage strengths. The product had brand and generic sales of roughly $484.4 million for the 12 months ended June 2017, according to QuintilesIMS data.