Allergan Receives FDA Complete Response Letter for Migraine Drug Semprana

By Pharma News - DCAT Publisher

July 1, 2014

Allergan has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) to its new drug application (NDA) for Semprana (dihydroergotamine), formerly referred to as Levadex, which is being developed as an acute treatment of migraine in adults. In the CRL, the FDA acknowledged that Allergan has made improvements in the canister-filling process.

The two specific items listed in the CRL are related to specifications around content uniformity on the improved canister-filling process and on standards for device actuation. There were no issues related to the clinical safety and efficacy of the product. Allergan received draft labeling from the FDA for the product in June 2013. Allergan plans to meet with the FDA and says it will work to fully address these issues to the satisfaction of the FDA. The company estimates that the next FDA action will occur by the end of the second quarter of 2015.

In other news, Allergan has received approval from the FDA for Ozurdex (dexamethasone intravitreal implant) as a new treatment option for diabetic macular edema  in adult patients who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic). Ozurdex  is a sustained-release biodegradable steroid implant.

Source: Allergan