Ahead of the Bell: FDA outlines MAP drug issues

Ahead of the Bell: FDA outlines MAP drug issues

March 28th, 2012 // 12:41 pm @

The Food and Drug Administration has asked drugmaker MAP Pharmaceuticals Inc. to address issues tied to chemistry, manufacturing and controls before it can decide whether to approve its potential migraine treatment Levadex.

The company’s shares fell $4.04, or 23.6 percent, to $13.10 in premarket trading Tuesday.

Regulators told the Mountain View, Calif., company in a letter that they have not finished their review of inhaler usability information, which was requested late in the FDA’s review cycle. The FDA also asked MAP to address “observations from a recent facility inspection of a third party manufacturer,” MAP said in a statement released Monday after markets closed.

The drugmaker said it will work with the FDA to address issues raised in the letter as quickly as possible. The company noted that regulators did not ask for additional studies and did not cite any potential safety issues or concerns about effectiveness.

MAP is working with Allergan Inc. to develop Levadex as an inhaled migraine treatment for adults, and the companies will share profits on sales of the drug if it is approved.

MAP said last August that the FDA had accepted its marketing application for Levadex, which triggered a $20 million payment from Allergan.

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