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Areva P0013 is an injectable small molecule pharmaceutical product currently under development by Areva Pharmaceuticals. The drug is being developed through the 505(b)(2) regulatory pathway, which typically involves a modification—such as a new dosage form, strength, or formulation—of a previously approved drug. Areva P0013 is available in 500mg and 1g dosage strengths. While the specific therapeutic indication and biological target have not been publicly disclosed, Areva Pharmaceuticals focuses primarily on injectable oncology and supportive care pharmaceuticals. The company expects to reach a milestone for an NDA/BLA filing in the fourth quarter of 2026.
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