According to these FDA rules, a company with a drug application acceptable for resubmission hears back from the agency within 14 days. If FDA continues to have problems with a resubmitted drug application, the company will also be informed but not necessarily within 14 days.
Navidea heard back from FDA in 14 days that the Lymphoseek resubmission was accepted. MAP Pharma is now on Day 29 of not hearing anything from FDA about the Levadex resubmission.
Levadex is an inhaled formulation of DHE, a drug already used in intravenous and nasal spray formulations to treat migraines. MAP Pharma developed a device that allows patients suffering from acute migraines to inhale the drug into their lungs, thereby accelerating pain relief.
FDA rejected Levadex in late March for what the company claims were outstanding problems related only to the manufacturing process for the device. The FDA did not raise safety concerns, including the possibility that migraine sufferers inadvertently take more than one Levadex dose at a time, MAP Pharma claimed. After meeting with FDA in June, MAP Pharma said it had all the data necessary to resubmit Levadex without needing to conduct new clinical trials or making additional refinements to the device.
MAP Pharma has been embroiled in FDA controversy in the past. The company had long claimed Levadex clinical trials were conducted under a Special Protocol Assessment (SPA) agreement with FDA. But later, MAP Pharma was forced to acknowledge that no Levadex SPA existed.
-- Reported by Adam Feuerstein in Boston.