Navigation Links
Questcor Receives Notification of PDUFA Date Extension to September 11, 2010
Date:6/13/2010

UNION CITY, Calif., June 11 /PRNewswire-FirstCall/ -- Questcor Pharmaceuticals, Inc. (Nasdaq: QCOR) today announced that it has received notification from the U.S. Food & Drug Administration (FDA) that the PDUFA date for Questcor's supplemental new drug application (sNDA) to approve Acthar for the treatment of infantile spasms (IS) has been extended to September 11, 2010.  The FDA extended the PDUFA date in order to review information regarding labeling and potential post-approval commitments that they solicited from Questcor. This follows the May 6, 2010 votes by the Advisory Committee to the Division of Peripheral and Central Nervous System Drugs of the FDA which indicated support for approval of this new Acthar indication.  

"We look forward to working with the FDA over the next few months in order to finalize these critical elements," said Don M. Bailey, President and CEO of Questcor.

Investors should note that there can be no assurance that the FDA will approve this sNDA by September 11, 2010, or thereafter.

About Questcor

Questcor Pharmaceuticals, Inc. is a pharmaceutical company that markets H.P. Acthar® Gel (repository corticotropin injection). H.P. Acthar Gel ("Acthar") is an injectable drug that is approved for the treatment of certain disorders with an inflammatory component, including the treatment of exacerbations associated with multiple sclerosis ("MS") and to induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that is
'/>"/>

SOURCE Questcor Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Questcor to Present at the Jefferies 2010 Global Life Sciences Conference
2. Trading Halted Today in Questcor Pharmaceuticals Common Stock
3. Questcor to Discuss Results From FDA Panel Meeting
4. Questcor Reports Solid Fourth Quarter Results
5. Mylan Receives Approval for Generic Version of Neurontin® Tablets
6. Jiangbo Pharmaceuticals, Inc. Receives Approval to List on the NASDAQ Global Market
7. Ardian(R) Receives 2010 EuroPCR Innovation Award and Demonstrates Further Durability of Renal Denervation Treatment for Hypertension
8. Amedica® Receives Patent for Hip Implant Using Monoblock Ceramic Technology
9. The Female Health Company Receives Order for 3.5 Million FC2 Female Condoms for Distribution at 2010 World Cup
10. PolyGel® Receives SADMERC Approval for L-Code L0627 for New ThermoActive™ Plus Cold & Hot Compression Lumbar Orthosis
11. Shire Receives LIALDA(R) Paragraph IV Notice Letter From Zydus Pharmaceuticals
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/5/2015)... 05, 2015 Research and Markets ( ... "India Pharma Outlook 2015: Accelerating growth to the next ... report to their offering. Domestic ... the 2013 caused by the market,s reaction to the ... to continue to be healthy, as the momentum continues ...
(Date:3/5/2015)... and HAMPTON, N.J. , March ... MNK ), a leading global specialty biopharmaceutical ... announced today that they have entered into a definitive ... Ikaria, Inc. from a Madison Dearborn -led investor ... Subject to customary closing conditions, the ...
(Date:3/5/2015)... 5, 2015 According to a ... Product (Systems and Disposables), by Type (Invasive, Minimally Invasive, ... and Ambulatory Sites) - Analysis & Global Forecast to ... expected to reach $1,107.4 Million by 2019 from $887.8 ... a CAGR of 4.5% during the forecast period. ...
Breaking Medicine Technology:India Pharma Outlook 2015: Accelerating growth to the next level - Moving up the value chain beyond Generics 2India Pharma Outlook 2015: Accelerating growth to the next level - Moving up the value chain beyond Generics 3Mallinckrodt Pharmaceuticals To Expand Hospital Growth Platform With Ikaria, Inc. Acquisition 2Mallinckrodt Pharmaceuticals To Expand Hospital Growth Platform With Ikaria, Inc. Acquisition 3Mallinckrodt Pharmaceuticals To Expand Hospital Growth Platform With Ikaria, Inc. Acquisition 4Mallinckrodt Pharmaceuticals To Expand Hospital Growth Platform With Ikaria, Inc. Acquisition 5Mallinckrodt Pharmaceuticals To Expand Hospital Growth Platform With Ikaria, Inc. Acquisition 6Mallinckrodt Pharmaceuticals To Expand Hospital Growth Platform With Ikaria, Inc. Acquisition 7Mallinckrodt Pharmaceuticals To Expand Hospital Growth Platform With Ikaria, Inc. Acquisition 8Mallinckrodt Pharmaceuticals To Expand Hospital Growth Platform With Ikaria, Inc. Acquisition 9Hemodynamic Monitoring Systems Market Worth $1,107.4 Million by 2019 2Hemodynamic Monitoring Systems Market Worth $1,107.4 Million by 2019 3Hemodynamic Monitoring Systems Market Worth $1,107.4 Million by 2019 4
... 30, 2012  Today, in conjunction with its Investor Day being ... PRXL ) announced forward-looking earnings expectations for the ... for Fiscal Year 2012, and for Fiscal Year 2013.  ... quarter of Fiscal Year 2012 and for all of Fiscal ...
...  Stiefel, a GSK (NYSE: GSK ) company, ... agreement for the acquisition by Stiefel of exclusive development ... in all territories outside of China, Taiwan, Macao and ... development for the treatment of psoriasis and atopic dermatitis. ...
Cached Medicine Technology:PAREXEL International Issues Earnings Guidance In Conjunction With Investor Day 2PAREXEL International Issues Earnings Guidance In Conjunction With Investor Day 3PAREXEL International Issues Earnings Guidance In Conjunction With Investor Day 4Stiefel, a GSK company, enters agreement with Welichem Biotech, Inc. to acquire a novel topical agent for psoriasis and atopic dermatitis 2
(Date:3/5/2015)... 05, 2015 Central Nebraska Imaging (CNI) ... including the brand’s new logo and optimized website. ... practice’s modern approach to expert diagnostic imaging, centered on ... be built to be a resource for Nebraska patients ... automated forms, communication and referral functionality, video content and ...
(Date:3/5/2015)... 05, 2015 HomeCEUConnection.com is ... with extra savings on their nutrition CEUs. ... health and nutrition, HomeCEUConnection.com is offering 10% ... promo code, NUTRITION2015 . , High ... , HomeCEUConnection.com provides high-quality continuing education courses ...
(Date:3/5/2015)... Angeles, CA (PRWEB) March 05, 2015 ... article titled “Butt Augmentation, Labiaplasty on the Rise, Plastic ... reported by the American Society for Aesthetic Plastic ... Surgeons . Both groups reported a year-over-year doubling of ... of the physicians quoted in the article, this increase ...
(Date:3/5/2015)... In honor of National Drug Facts Week, ... and alcohol abuse in schools and communities across America, ... information on some of the dangers and statistics involved ... Institute on Drug Abuse, this annual promotion of the ... illusions that teens and young adults get from television, ...
(Date:3/5/2015)... At the 7th Annual Mississippi Addiction ... treatment met today in Jackson, Mississippi to listen to ... the numerous respected speakers will be William S. ... that pain medications have had in today’s opiate overdose ... "It is hard to believe that much of the ...
Breaking Medicine News(10 mins):Health News:Central Nebraska Imaging Center Gets Rebranding 2Health News:HomeCEUConnection.com Offers Nutrition CEUs this March to Celebrate Nutrition Month 2Health News:The Kim Kardashian and Jennifer Lopez Effect: Butt Augmentations Double from 2013 to 2014 2Health News:A Forever Recovery Issues New Tips for Sobriety for National Drug Facts Week 2Health News:National Addiction Treatment Expert William S. “Bill” Jacobs, Md Speaks At Prestigious 7th Annual Mississippi Addiction Conference 2Health News:National Addiction Treatment Expert William S. “Bill” Jacobs, Md Speaks At Prestigious 7th Annual Mississippi Addiction Conference 3
... neither improved nor deteriorated. There are 89 new cases, 2 deaths ... the number of dengue cases at the All India Institute of ... viral fever cases is also decreasing; however, the doctors cautioned that ... cases have come down but the outbreak isn't over," said Medical ...
... hopes of a team of eminent plastic surgeons led by ... waiting for the// final approval from The Royal Free hospital’s ... transplant which would involve the complete replacement of a disfigured ... ,Although the hospital had granted permission to ...
... in clinical use for decades, a small, sweet-tasting compound ... cure for epilepsy.// ,2-deoxy-glucose, or 2DG, has ... cancer imaging studies in humans. But now, researchers at ... blocks the onset of epileptic seizures in laboratory rats. ...
... must get its act together to check the perilous trend of ... suggested a cap on the// embryo, allowing only one embryo at ... the Human Fertilization and Embryology Authority (HFEA) has suggested that the ... two to one for patients who are not on the wrong ...
... Taxotere(docetaxel) from Sanofi-Aventis has been approved for its treatment ... showed that patients given chemotherapy with// Taxotere survived an ... to 8.3 months with standard drugs. ,The ... cisplatin and fluorouracil chemotherapy in locally advanced squamous cell ...
... gene therapy for Parkinson's disease has given the green signal ... symptoms for patients,// according to the reports of two groups ... and last week the researchers reported that each of the ... received some benefit and none had significant side effects. ...
Cached Medicine News:Health News:Commonplace Sugar Compound Silences Seizures 2Health News:Commonplace Sugar Compound Silences Seizures 3Health News:Gene therapy Beneficial in Parkinson's Disease 2Health News:Gene therapy Beneficial in Parkinson's Disease 3
... a vital dye, used in matured cataract ... fibrous tissue enables the surgeon to see ... preparation of trypan blue combined with sodium ... tolerated following intraocular injection into the anterior ...
Exclusive oxidized regenerated cellulose technology. The only oxidized regenerated cellulose hemostat line, surgicel absorbable hemostat delivers a unique combination of effectiveness, absorbability,...
Refkeratometer...
Portable, easy to align, automatic measurement, automatic fogging. Accurate and dependable readings. Infrared printer communication. Rechargeable battery. Integrates with the TRS-2100 and EPIC-2100 r...
Medicine Products: