Alembic Pharmaceuticals' associate company -- Rhizen Pharmaceuticals SA -- has received Fast Track Designation for RP6530 (tenalisib) from United States Food & Drug Administration (USFDA). RP6530 (tenalisib) is a highly selective and orally active dual PI3K delta/gamma inhibitor, for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL).
Fast Track Designation is awarded to drugs that treat a serious condition and fill an unmet medical need. Fast Track Designation enables the recipient to have more frequent interaction with and support from FDA, both through meetings and written communications, and also makes the drug eligible for Accelerated Approval and Priority Review.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907. The company manufactures and markets generic pharmaceuticals products all over the world.