Navigation Links
MAP Pharmaceuticals Receives Complete Response Letter from FDA for LEVADEX® (dihydroergotamine) NDA
Date:3/26/2012

MOUNTAIN VIEW, Calif., March 26, 2012 /PRNewswire/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced that the United States Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for LEVADEX® (dihydroergotamine) inhalation aerosol.

In the Complete Response letter, the FDA requested that the Company address issues relating to chemistry, manufacturing and controls (CMC) and observations from a recent facility inspection of a third party manufacturer. The FDA also indicated that it had not been able to complete review of inhaler usability information requested late in the review cycle by the FDA.  

The FDA did not cite any clinical safety or efficacy issues, nor did the FDA request that any additional clinical studies be conducted prior to approval.  The Company is pleased with the FDA-provided revisions to product labeling and packaging, including correct use of the LEVADEX trade name. The Company continues to pursue approval of LEVADEX for the acute treatment of migraine in adults.

MAP Pharmaceuticals plans to request a meeting with the FDA to discuss the issues raised in the Complete Response letter.

"MAP is committed to making this important new therapy available to people who experience migraine. We will continue to work closely with the FDA to finalize our product labeling and to address the issues raised in the Complete Response letter as quickly as possible," said Timothy S. Nelson, President and Chief Executive Officer of MAP Pharmaceuticals.

Conference Call Information

MAP Pharmaceuticals management will host a conference call on Tuesday, March 27, 2012 at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time) and individuals may participate in the conference call by dialing (877) 291-1367 (domestic) or  (253) 237-1128 (international). To access the webcast, please visit the Company's website at www.mappharma.com  and go to the Investor Relations page. A replay of the webcast will be available approximately two hours after the call.

About MAP Pharmaceuticals

MAP Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing new therapies to address undermet patient needs in neurology. The Company is developing LEVADEX®, an orally inhaled investigational drug for the acute treatment of migraine. The New Drug Application for LEVADEX is currently under review by the U.S. Food and Drug Administration. MAP Pharmaceuticals has entered into a collaboration agreement with Allergan, Inc. to co-promote LEVADEX to neurologists and pain specialists in the U.S. and Canada. The Company also applies its proprietary drug particle and inhalation technologies to generate new pipeline opportunities by enhancing the therapeutic benefits of proven drugs, while minimizing risk by capitalizing on their known safety, efficacy and commercialization history. Additional information about MAP Pharmaceuticals can be found at http://www.mappharma.com.

LEVADEX and TEMPO are trademarks of MAP Pharmaceuticals, Inc.

Forward-Looking Statements

In addition to statements of historical facts or statements of current conditions, this press release contains forward-looking statements, including with respect to MAP Pharmaceuticals' LEVADEX product candidate. Actual results may differ materially from current expectations based on risks and uncertainties affecting the company's business, including, without limitation, risks and uncertainties relating to the regulatory approval process for the Company's LEVADEX product candidate. The reader is cautioned not to unduly rely on the forward-looking statements contained in this press release. MAP Pharmaceuticals expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Additional information on potential factors that could affect MAP Pharmaceuticals' results and other risks and uncertainties are detailed in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2011, available at http://edgar.sec.gov.

MAP Pharmaceuticals Contact:

Christopher Chai, 650-386-3107 (investors)
Lisa Borland, 650-386-3122 (media)
Denise Powell 510-703-9491 (media)


'/>"/>
SOURCE MAP Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. AcelRx Pharmaceuticals Reports Fourth Quarter and Full-Year 2011 Financial Results
2. Pharmaceuticals: Global Industry Guide
3. Avanir Pharmaceuticals Announces Appointment of Rohan Palekar as Chief Commercial Officer
4. JacksonWhite Files Overtime Lawsuit Against Sunovion Pharmaceuticals
5. Arena Pharmaceuticals Announces Fourth Quarter and Full Year 2011 Financial Results and Reviews Recent Developments
6. Omnicell to Exhibit at Dubai International Pharmaceuticals and Technologies Conference and Exhibition
7. Arena Pharmaceuticals to Host Business and Financial Update Conference Call and Webcast on Wednesday, March 14
8. Auxilium Pharmaceuticals to Present at the 2012 Barclays Capital Global Healthcare Conference
9. S1 Pharmaceuticals Announces New Executive Management and Scientific Advisory Board Appointments
10. Questcor Pharmaceuticals to Present at the 24th Annual ROTH Conference on March 12, 2012
11. Patented Protection Against Counterfeit Pharmaceuticals and Retail Fraud. ICAP Patent Brokerage Announces for Auction a Patented System for Verification of Purchase and Product Legality
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... Research and Markets has announced the ... to 2022" report to their offering. ... patients with kidney failure, it replaces the function of kidneys ... blood and thus the treatment helps to keep the patient ... Increasing number of ESRD patients & substantial ...
(Date:6/23/2016)... Roche (SIX: RO, ROG; OTCQX: RHHBY) announced ... BRAHMS PCT (procalcitonin) assay as a dedicated testing solution ... this clearance, Roche is the first IVD company in ... sepsis risk assessment and management. PCT is ... levels in blood can aid clinicians in assessing the ...
(Date:6/23/2016)... Bracket , a leading clinical trial technology and specialty ... Bracket eCOA (SM) 6.0, at the 52 nd ... in Philadelphia , Pennsylvania.  A demonstration of ... its kind to fully integrate with RTSM, will be held ... a flexible platform for electronic clinical outcomes assessments that is ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... ... Austin residents seeking Mohs surgery services, can now turn to Dr. Jessica Scruggs ... for medical and surgical dermatology. , Dr. Dorsey brings specialization to include Mohs surgery, ... Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn Goldstein, MD, ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin ... injury. Recently, he has implemented orthobiologic procedures as a method for treating his ... of the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic ...
(Date:6/24/2016)... ... 2016 , ... June 19, 2016 is World Sickle Cell Observance Day. In ... benefits of holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued ... Sickle Cell Disease (SCD) is a disorder of the red blood cells, which can ...
(Date:6/24/2016)... Diego, CA (PRWEB) , ... June 24, 2016 , ... ... with the American Cancer Society and the Road To Recovery® program to drive cancer ... to seniors and other adults to ensure the highest quality of life and ongoing ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Investment Group (TGIG), has initiated cultivation and processing operations at its production facility, ... Pahrump, Nevada. , Puradigm is the manufacturer of a complete system of proactive ...
Breaking Medicine News(10 mins):