Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Allergan Manufacturing Headaches Continue For Semprana

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Inhalable acute migraine drug previously known as Levadex receives third “complete response” letter from FDA.

You may also be interested in...

Allergan’s Manufacturing Challenges Produce Second Levadex “Complete Response” Letter

FDA again cites inspection issues related to a third-party facility where the product canister for the migraine drug is manufactured, as well as the manufacturing process itself; Allergan says it recently completed an acquisition of that third-party firm, thereby bringing the inhaled treatment’s manufacturing in-house.

Allergan Buys MAP To Chart Migraine Franchise Growth

Allergan partnered with MAP in 2011 for rights to commercialize Levadex for acute migraine in North America, but now will control 100% of the product’s revenue, creating a complementary product to Botox in chronic migraine. Levadex has an April 15 PDUFA date at FDA.

Seagen CEO Search Under Way As Longtime Leader Siegall Resigns In Scandal

Chief medical officer Roger Dansey has stepped in as interim CEO until a new one is appointed.


Related Companies




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts