This site is intended for Healthcare professionals only.

Orphan drug designation for Alembic Pharma cancer drug: USFDA


Orphan drug designation for Alembic Pharma cancer drug: USFDA

New Delhi: Drug firm Alembic Pharmaceuticals said the US health regulator has granted orphan drug designation to its associate company Rhizen Pharmaceuticals SA’s RP6530 used for the treatment of cancer.

The US Food and Drug Administration (USFDA) has granted orphan drug designation for Tenalisib (RP6530)… for the treatment of patients with peripheral T-cell lymphoma (PTCL), Alembic Pharmaceuticals said in a BSE filing.

The USFDA grants orphan drug designation to a drug or biological product intended to treat a rare disease in the United States.

“A number of incentives are provided for an orphan-drug such as 7-year marketing exclusivity, tax credits for clinical development costs, exemption/waiver of application fees and assistance from FDA Office of Orphan Products Development (OOPD) during the process,” the company added.

Earlier this month, the USFDA had granted fast track designation to Rhizen Pharmaceuticals SA’s RP6530. Fast track designation is awarded to drugs that treat a serious condition and fill an unmet medical need.



Source: PTI
0 comment(s) on Orphan drug designation for Alembic Pharma cancer drug: USFDA

Share your Opinion Disclaimer

Sort by: Newest | Oldest | Most Voted