Specialty pharma company NuPathe Inc. (PATH) announced that it has resubmitted its New Drug Application or NDA to the U.S. Food and Drug Administration or FDA for its migraine patch NP101.
NuPathe said it expects confirmation from the FDA regarding acceptance, resubmission classification and Prescription Drug User Fee Act (PDUFA) goal date within the next few weeks. The company continues to expect a six-month review by FDA.
"With the additional data and enhancements made to the patch, we have submitted a strong application and have an even more attractive commercial opportunity designed to address the needs of the nearly half of migraine patients who frequently experience both headache pain and migraine-related nausea," said Jane Hollingsworth, chief executive officer of NuPathe.
In August 2011, NuPathe had said the U.S. Food & Drug Administration sought additional data, while considering the company's New Drug Application for its migraine patch NP101 or Zelrix. The company had said it received a Complete Response Letter, or CRL, from the FDA, which contains chemistry, manufacturing and safety questions.
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