Hanmi oral cancer treatment gets approval from U.S. FDA

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Hanmi oral cancer treatment gets approval from U.S. FDA

Hanmi Pharmaceutical said Friday that its oral treatment for cancer has received a special designation from the U.S. Food and Drug Administration (FDA).

Oraxol, a novel oral formulation commonly used during chemotherapy treatment for angiosarcoma and other related conditions, has received an Orphan Drug Designation (ODD), the company said.

The FDA grants ODD status to drugs intended for the safe and effective treatment of rare diseases and disorders that affect fewer than 200,000 people in the United States.

The ODD status provides certain benefits, including a seven-year period of market exclusivity if the drug is approved, as well as a tax reduction.

Hanmi said the drug has been licensed to global biopharmaceutical company Athenex for all major worldwide territories outside of Korea.


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