Allergan Receives Complete Response Letter from FDA for Levadex New Drug Application - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Allergan Receives Complete Response Letter from FDA for Levadex New Drug Application


Allergan received a complete response letter (CRL) from FDA to its new drug application (NDA) for Levadex (dihydroergotamine) inhalation aerosol for the acute treatment of migraine in adults, the company said in a press release. The main manufacturing issues cited in the CRL, which were identified by FDA in prior discussions, have already been addressed by Allergan. In addition, Allergan received draft labeling from FDA. The company estimates that the next FDA action will occur by the end of Q4 2013.

In a previous inspection, FDA noted concerns with Exemplar Pharma, the canister filling-unit manufacturer. Allergan subsequently completed the acquisition of Exemplar on April 12, 2013, In accordance with Allergan's overall manufacturing strategy to secure their supply chain. Senior members of Allergan's Global Technical Operations will oversee the facility. Allergan anticipates that FDA will require reinspection of the Exemplar facility prior to approval. FDA also noted concerns regarding the manufacturing process for the final filled canisters, and Allergan has responded to this concern.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race

Click here