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    Orphan drug designation for Alembic Pharma cancer drug: USFDA

    Written by Ruby Khatun Khatun Published On 2017-12-27T10:00:39+05:30  |  Updated On 27 Dec 2017 10:00 AM IST
    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.

    Alembic PharmaAlembic Pharmaceuticalsbiological productcancercancer drugFDAorphan drug designationOrphan Products Developmentperipheral T- cell lymphomapharma newsreceivesRhizen Pharmaceuticals SARP6530tenalisibUS Food and Drug AdministrationUSFDA
    Source : PTI

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    Ruby Khatun Khatun
    Ruby Khatun Khatun
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