FDA Rejects New Drug for Migraines

 Posted on May 23, 2013 in Drugs

A few short weeks ago, Allergan spent close to $1 billion on rights to a new drug for treating migraine headaches. However, the FDA has already rejected his product. A recent New York Times article has taken a closer look at the ordeal.

According to Allergan, the Food and Drug Administration rejected the new drug, called Levadex, due to concerns about the manufacturing of the inhaler that is required to dispense it.

Levadex is a unique kind of migraine drug that uses an inhaler. The inhaler is very similar to those used for asthma.

It was back in January that Allergan initially accepted the price of $958 million in order to acquire MAP Pharmaceuticals, which is the company that developed Levadex. This deal closed in March.

This wasn't the first time the FDA has rejected Levadex. In March 2012 it was also declined approval due to, again, concerns about the inhaler. MAP was confident that Levadex would be approved the second time around, as illustrated by Allergan's agreement to purchase the company before waiting for the FDA's official second decision.

It has been said that the FDA declined approval for the second time because of an inspection of the company that was filling the canisters. There were also concerns about the manufacturing process for the final filled canisters.

In response to the second rejection, Allergan has made efforts to address the issues. It has recently acquired the canister-filling company Exemplar Pharma and has arranged for its own executives to run the operation.

According to the company's news release, “Allergan is committed to vigorously address the concerns raised by the FDA.” The company is hoping to have a third chance for approval at the end of this year.

Allergan is based in Irvine, California. It is well known for its drug Botox, which is used to treat various medical conditions and smooth wrinkles.

Levadex has been rejected, but it is not uncommon for drugs that can be potentially harmful to be mistakenly approved by the FDA. If you have suffered do to improperly prescribed, or defective, drugs, contact a dedicated Illinois defective medical attorney immediately to review your case.