March 28, 2013 / 11:26 AM / in 5 years

AP Pharma's drug for chemotherapy-induced nausea denied approval

March 28 (Reuters) - U.S. health regulators denied approval to A.P. Pharma Inc’s drug for treating chemotherapy-induced nausea and vomiting, and asked for additional analysis of existing late-stage data on the drug.

The U.S. Food and Drug Administration also asked for a study that can test the usability of the drug’s syringe system.

The agency had earlier rejected the approval of the drug, APF530, in March 2010, citing concerns about its two-syringe administration system and deficiencies in the company’s contract manufacturing facilities.

A.P. Pharma resubmitted its application in September last year after switching to a single-syringe system and conducting additional metabolism studies as required by the FDA.

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