Tris Pharma, a specialty pharmaceutical company focused on developing innovative drug delivery technologies, announced that its generic pharmaceuticals business has launched dextroamphetamine sulfate oral solution, the first-to-market generic equivalent of ProCentra, which is indicated for the treatment of attention deficit disorder with hyperactivity (ADHD) and narcolepsy.
“Dextroamphetamine sulfate oral solution continues Tris’ track record of bringing first-ever generics to the marketplace, as it’s our fourth first-to-market generic product and the first of many to be launched through our new generic pharmaceuticals business,” said Ketan Mehta, president and CEO of Tris Pharma.
“With 13 FDA-approved ANDA products and a robust pipeline of ANDA development projects, we look forward to launching many more difference-making specialty generics,” said Janet Penner, president of Tris’ generic pharmaceuticals business.
Manufactured at Tris’ US Food and Drug Administration (FDA)-inspected, state-of-the-art facility in Monmouth Junction, NJ, dextroamphetamine sulfate oral solution is now available in the US through wholesalers and distributors, as well as directly to the trade. Dextroamphetamine sulfate oral solution was approved by the FDA on May 29, 2013. It is distributed in accordance with FDA and US Drug Enforcement Administration (DEA) regulations governing the handling of CII controlled substances.