By USFDA
Alembic Pharmaceuticals announced that its associate company, Rhizen Pharmaceuticals S.A (Rhizen) has been granted by the USFDA the orphan-drug designation for the active moiety of Tenalisib (RP6530), the company's highly selective and orally active dual PI3K delta/ gamma inhibitor, for the treatment of peripheral T-cell lymphoma (PTCL).The orphan-drug designation is granted 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 a 7-year marketing exclusivity, tax credit for clinical development costs, exemption/ waiver of application (filing) fees and assistance from the USFDA office of Orphan Products Development during the development process.
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