Glenmark Pharmaceuticals revealed that its anti-diarrhea drug manufactured in partnership with Salix Pharmaceuticals has been approved by the US Food and Drug Administration.
The company said that the drug, Crofelemer 125 mg, has been approved for treating diarrhea in HIV/AIDS patients and those on anti-retroviral therapy.
Crofelemer has been developed by Glenmark who acquired the license to manufacture it from Napo Pharmaceuticals who had initially discovered the major compound used in the drug.
"This is a significant approval milestone and will enable the first NCE launch by Glenmark across emerging markets. Most importantly, this is a significant step forward in addressing the unmet medical need of people with HIV/AIDS on anti-retovirals who experience non-infectious diarrhea, which often can lead to reduced treatment compliance. This will also help us accelerate filing across countries and also propel our development in additional diarrhea indications including the acute indications", Genlmark's chairman, Glenn Saldanha said.