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:1/17/2017)... 2017 Research and Markets has announced the ... report to their offering. ... The global artificial pancreas devices system market to ... Global Artificial Pancreas Devices System Market 2016-2020, has been prepared ... The report covers the market landscape and its growth prospects over ...
(Date:1/17/2017)... , Jan. 17, 2017 Paragon Bioservices received ... product development services for a variety of ... medical product development activities. The IDIQ mechanism ... pool for task order awards up to $159 ... in manufacturing and process development of biopharmaceuticals, is ...
(Date:1/17/2017)... 2017  Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) ... in a Phase 3 clinical trial comparing the efficacy ... in the prevention of hepatic veno-occlusive disease (VOD) in ... (HSCT) who are at high risk or at very ... will be conducted across approximately 100 medical centers in ...
Breaking Medicine Technology:
(Date:1/17/2017)... ... January 17, 2017 , ... In the crowded ... is a stand-out company for several differences from other mainstream brands. , ... demand, this is called 'Agile' manufacturing - http://www.leanproduction.com/agile-manufacturing.html . It allows them ...
(Date:1/17/2017)... ... January 17, 2017 , ... ... events, Dr. Carol Francis re-releases powerfully uplifting interview with medical expert and prolific ... everyone endure and pass through tough times, Dr. Bernie Siegel energizes listeners to ...
(Date:1/17/2017)... ... ... SunView Software’s Service Smart Technology has been selected as a finalist for ... year, Pink Elephant recognizes a new product or service developed by an IT services ... opportunity. The award highlights original innovations that were released in 2016, either as a ...
(Date:1/17/2017)... , ... January 17, 2017 , ... ... enthusiasts at the National Association of Music Merchants (NAMM) winter trade show, Booth ... 2017. , Etymotic’s ER•4® has long been the gold standard for high-definition, in-ear ...
(Date:1/17/2017)... ... January 17, 2017 , ... Achieve TMS West, with multiple ... new office in San Clemente, California this month. Achieve TMS West is the ... treating individuals struggling with major depression. Depression impacts over 15 million adults in ...
Breaking Medicine News(10 mins):