Navigation Links
FDA Accepts Noven's NDA For An Investigational Nonhormonal Therapy For Menopausal Vasomotor Symptoms
Date:11/12/2012

MIAMI, FL and NEW YORK, NY, Nov. 12, 2012 /PRNewswire/ -- Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced that its New Drug Application (NDA) for low-dose mesylate salt of paroxetine (LDMP; 7.5 mg) for the treatment of moderate to severe vasomotor symptoms (hot flashes and night sweats) due to menopause has been accepted for filing by the U.S. Food and Drug Administration (FDA). 

The acceptance of the NDA reflects the FDA's determination that the application is sufficiently complete to permit a substantive review. The NDA has been assigned a Prescription Drug User Fee Act (PDUFA) action date of June 28, 2013, which represents the goal date for the FDA to complete its review of the NDA.

In addition, the FDA advised Noven that the NDA for LDMP will be discussed at a meeting of the FDA's Reproductive Health Drugs Advisory Committee tentatively scheduled for March 4, 2013. 

Low-dose mesylate salt of paroxetine (LDMP) is an investigational oral nonhormonal therapy using 7.5 mg of paroxetine mesylate that was specifically developed for the treatment of vasomotor symptoms due to menopause. Noven submitted the LDMP NDA in August 2012. 

About Noven

Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacturing, marketing and sale of prescription pharmaceutical products. Noven is committed to developing and offering products and technologies that meaningfully benefit patients, its customers and its industry partners. Noven is a stand-alone operating subsidiary of Japan-based Hisamitsu Pharmaceutical Co., Inc., and serves as Hisamitsu's U.S. growth platform in prescription pharmaceuticals. For more information about Noven, visit www.noven.com. For information about Hisamitsu, visit www.hisamitsu.co.jp/english.

Contact

Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.
305-253-1916

 


'/>"/>
SOURCE Noven Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Sanofi Pasteur Presents Pediatric Data on Investigational Quadrivalent Influenza Vaccine
2. Data from Study of Elderly Depressed Patients are Reported for Investigational Compound Lu AA21004 on Symptoms of Major Depressive Disorder (MDD)
3. Ambit Biosciences and Teva Announce Clearance of an Investigational New Drug (IND) Application for CEP-32496, A Novel BRAF(V600E) Inhibitor
4. Results of Phase II Study of Boehringer Ingelheims Investigational Bronchodilator for COPD Presented at 2012 ATS International Conference
5. Lilly Diabetes Presents Phase II Blood Pressure and Heart Rate Data on Investigational GLP-1 Analog Candidate, Dulaglutide, in Patients with Type 2 Diabetes at the 27th American Society of Hypertension Scientific Meeting
6. Lilly and Boehringer Ingelheim Present Data at the 72nd American Diabetes Association Scientific Sessions® from Phase II Studies Comparing Investigational Novel Basal Insulin to Insulin Glargine
7. Abbott Presents Results of Clinical Studies Evaluating Its Investigational Treatment for Advanced Parkinsons Disease
8. Results For Phase 2b Trial Of Unique Investigational Cell-Based Therapy In Venous Leg Ulcers Published In The Lancet
9. Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab
10. Clinical Study With Investigational Cream Aims To Help Women Who Experience Painful Sex
11. Omeros Files Investigational New Drug Application for Lead Compound in PDE10 Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... Feb. 5, 2016 ... the "Global Obstetrics Partnering 2010-2016: Deal ... to their offering. --> http://www.researchandmarkets.com/research/hcdvg6/global_obstetrics ... "Global Obstetrics Partnering 2010-2016: Deal trends, ... their offering. --> Research and ...
(Date:2/4/2016)... LONDON , Feb. 4, 2016 ... to achieve significant growth as next generation systems ... and use radiology for cancer surgery. New systems ... radiological overdosing that has been such a problem ... be delivered. Radiosurgery robots take cancer surgery far ...
(Date:2/4/2016)... 2016  Montoya Love is recognized by Continental Who,s ... Pharmaceuticals. Montoya is the Regulatory Systems Operations Manager with ... Manufacturing and selling a broad range ... provides healthcare institutions, clinical laboratories and life science researchers ... the globe. ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... February 05, 2016 , ... At its annual meeting held last ... Chairman of the National Board of Directors. Mr. McDermott succeeds former APDA Chairman, Fred ... Leslie A. Chambers , APDA President and CEO. “Pat has tirelessly served APDA ...
(Date:2/5/2016)... ... February 05, 2016 , ... Dr. Ben Amini, a ... is now welcoming orthodontist, Dr. Amanda Cheng, to the practice. With the addition ... health care, including general dentistry, cosmetic treatments, periodontics, implant dentistry , endodontics, ...
(Date:2/5/2016)... ... February 05, 2016 , ... Health and wellness is a topic ... in the event they are experiencing an illness. Migraines are a severe form of ... afflicted with migraines would not wish the pain on their worst enemy, the feeling ...
(Date:2/5/2016)... ... February 05, 2016 , ... Calls Blacklist has just been updated ... interface design and the developer has fixed known bugs within the app. Calls Blacklist ... their phone while not consuming any of their device’s battery power or memory. It ...
(Date:2/5/2016)... , ... February 05, 2016 , ... Susan Polk ... San Luis Obispo users can expect to see in 2016. To view the report, ... significant changes will directly impact many San Luis Obispo seniors who rely on Medicare ...
Breaking Medicine News(10 mins):