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Cellceutix Receives FDA Orphan Drug Designation for Kevetrin

Vivien Diniz
Jan. 21, 2016 12:02PM PST
Biotech Investing

Cellceutix Corporation (OTC:CTIX) announced received the letter from the US Food and Drug Administration (FDA) granting Orphan Drug Designation to Kevetrin for the treatment of pancreatic cancer.

Cellceutix Corporation (OTC:CTIX) announced received the letter from the US Food and Drug Administration (FDA) granting Orphan Drug Designation to Kevetrin for the treatment of pancreatic cancer.
According to the company’s press release:

The FDA’s Orphan Drug Designation program allows special incentives for sponsors planning to test a product for use in a rare disease or condition, defined as affecting fewer than 200,000 people in the United States. These incentives include federal grants, tax credits, and reduced filing fees during development or at the time of application for marketing approval. If approved for commercialization by the FDA, the product may qualify for seven years of marketing exclusivity in the United States.

Leo Ehrlich, Chief Executive Officer at Cellceutix commented:

Receiving another Orphan Drug designation for Kevetrin, along with the previously announced designation for ovarian cancer, is an important milestone in our strategies for Kevetrin and emphasizes the possibilities of a unique drug like Kevetrin’s use in hard-to-treat diseases,

Click here to view the full press release. 

orphan-drug-designation rare-disease orphan-drug food-and-drug-administration united-states pancreatic-cancer
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