FDA approves first non-hormonal treatment for menopausal hot flashes
June 28 (Reuters) - The U.S. Food and Drug Administration approved Noven Therapeutics LLC's drug to treat hot flashes associated with menopause - a surprise decision as an advisory committee to the...
View ArticleHisamitsu Wins U.S. Approval for Drug to Ease Hot Flashes
Hisamitsu Pharmaceutical Co. (4530)’s Noven unit won U.S. approval for its drug to ease hot flashes associated with menopause. The Food and Drug Administration said today it cleared the drug, to be...
View ArticleFDA approves an antidepressant for hot flashes
Is it hot in here, or am I just depressed? For many menopausal women, hot flashes are just depressing. And depression, which affects at least one in four women ages 40 to 59, can intensify the misery...
View ArticleNoven Receives FDA Approval for Brisdelle™ (Paroxetine) Capsules, the First...
Brisdelle™ is the first and only FDA-approved nonhormonal therapy clinically proven to treat moderate to severe menopausal vasomotor symptoms Tweet Send to a Friend MIAMI, FL and NEW YORK, NY, June...
View ArticleFDA approves nonhormonal treatment for hot flashes
The Food and Drug Administration recently approved a new nonhormonal medication to relieve hot flashes and night sweats in women experiencing menopause. Brisdelle contains paroxetine, the active...
View ArticleNoven wins FDA approval for first non-hormonal drug to treat menopausal...
The U.S. Food and Drug Administration has approved a new, non-hormonal medication for treating hot flashes and night sweats in women that was developed by Miami-based Noven Pharmaceuticals. The...
View ArticleF.D.A. Approves a Drug for Hot Flashes
The first nonhormonal drug to treat hot flashes won approval from the Food and Drug Administration on Friday, offering a new alternative to menopausal women. The move was surprising because an...
View ArticleNoven Receives FDA Approval for Brisdelle™ (Paroxetine) Capsules, the First...
(Source: Hisamitsu Pharmaceutical Co Ltd) Noven Receives FDA Approval for BrisdelleTM (Paroxetine) Capsules, the First Nonhormonal Therapy for Vasomotor Symptoms Associated with Menopause Brisdelle™...
View ArticleNOVEN ACQUIRES COMMERCIAL RIGHTS TO MINIVELLE™ (ESTRADIOL TRANSDERMAL...
Miami, FL and New York, NY, December 3, 2012 -- Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced that it has acquired commercial rights to...
View ArticleF.D.A. Panel Advises Against Two Medicines to Treat Hot Flashes
Menopausal women looking for an approved alternative to hormones to treat hot flashes will probably not be getting immediate relief. Outside advisers to the Food and Drug Administration on Monday...
View ArticleMinivelle™ (Estradiol Transdermal System), The Smallest Estrogen Patch, Now...
Provides Effective Relief from Hot Flashes and Night Sweats Due to Menopause Google...
View ArticleMINIVELLE™ (ESTRADIOL TRANSDERMAL SYSTEM), THE SMALLEST ESTROGEN PATCH, NOW...
(Source: Noven Pharmaceuticals Inc) MINIVELLE™ (ESTRADIOL TRANSDERMAL SYSTEM), THE SMALLEST ESTROGEN PATCH, NOW AVAILABLE IN U.S. PHARMACIES Provides Effective Relief from Hot Flashes and Night Sweats...
View ArticleNOVEN SUBMITS NEW DRUG APPLICATION FOR INVESTIGATIONAL NON-HORMONAL THERAPY...
NOVEN SUBMITS NEW DRUG APPLICATION FOR INVESTIGATIONAL NON-HORMONAL THERAPY FOR MENOPAUSAL VASOMOTOR SYMPTOMS Miami, FL and New York, NY, August 29, 2012 -- Noven Pharmaceuticals, Inc., a wholly-owned...
View ArticleNOVEN ANNOUNCES FDA ADVISORY COMMITTEE VOTE ON INVESTIGATIONAL LOW-DOSE...
(Source: Noven Pharmaceuticals Inc) NOVEN ANNOUNCES FDA ADVISORY COMMITTEE VOTE ON INVESTIGATIONAL LOW-DOSE MESYLATE SALT OF PAROXETINE (LDMP) FOR VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE Miami,...
View ArticleNOVEN ANNOUNCES POSITIVE PHASE 3 DATA RESULTS FOR INVESTIGATIONAL LOW-DOSE...
Data from 12- and 24-Week Pivotal Studies Selected to Be Presented at The North American Menopause Society Annual Meeting , FL, NEW YORK, NY and , Oct. 3, 2012 /PRNewswire/ -- Noven Pharmaceuticals,...
View ArticleFDA Accepts Noven's NDA For An Investigational Nonhormonal Therapy For...
Google , FL and , 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...
View ArticleFDA ACCEPTS NOVEN’S NDA FOR AN INVESTIGATIONAL NONHORMONAL THERAPY FOR...
FDA ACCEPTS NOVEN'S NDA FOR AN INVESTIGATIONAL NONHORMONAL THERAPY FOR MENOPAUSAL VASOMOTOR SYMPTOMS Miami, FL, New York, NY, November 12, 2012 -- Noven Pharmaceuticals, Inc., a wholly-owned...
View ArticleNoven Pharmaceuticals, Inc. press release : FDA accepts Noven's NDA for an...
FDA ACCEPTS NOVEN'S NDA FOR AN INVESTIGATIONAL NONHORMONAL THERAPY FOR MENOPAUSAL VASOMOTOR SYMPTOMS Miami, FL and New York, NY, November 12, 2012 - Noven Pharmaceuticals, Inc., a wholly- owned...
View ArticleMenopause Publishes Pivotal Trial Results for Brisdelle™ (Paroxetine)...
MIAMI, FL and NEW YORK, NY, Sept. 18, 2013 /PRNewswire/ -- Noven Pharmaceuticals, Inc., today announced the publication of results from its two Phase 3 clinical studies in Menopause, the...
View ArticleNoven Pharmaceuticals, Inc. press release :First and Only FDA-approved,...
(Source: Hisamitsu Pharmaceutical Co Ltd) First and Only FDA-approved, Non-Hormonal Treatment for Moderate to Severe Hot Flashes Now Available by Prescription in U.S. Pharmacies The availability of...
View ArticleData on Brisdelle™ (Paroxetine) Capsules, the First and Only FDA-Approved...
Download image Noven Pharmaceuticals, Inc. (PRNewsFoto/Noven Pharmaceuticals, Inc.) MIAMI, Fla. and NEW YORK, N.Y., Oct. 2, 2013 /PRNewswire/ -- Noven Pharmaceuticals, Inc., today announced that 11...
View ArticleShionogi Inc. Announces Co-Promotion Agreement with Noven Pharmaceuticals For...
FLORHAM PARK, N.J., Jan. 13, 2014 /PRNewswire/ -- Shionogi Inc. today announced that it has entered into an exclusive, multi-year agreement with Noven Pharmaceuticals to co-promote Brisdelle™...
View ArticleSHIONOGI INC. ANNOUNCES CO-PROMOTION AGREEMENT WITH NOVEN PHARMACEUTICALS FOR...
(Source: Shionogi & Co Ltd) SHIONOGI INC. ANNOUNCES CO-PROMOTION AGREEMENT WITH NOVEN PHARMACEUTICALS FOR BRISDELLE™ (PAROXETINE) CAPSULES FLORHAM PARK, NJ (January 13, 2014) - Shionogi Inc. today...
View ArticleNoven Enters Co-Promotion Agreement with Shionogi for Brisdelle™ (Paroxetine)...
Co-Promotion to Extend Physician Awareness of the First and Only FDA-Approved, Non-Hormonal Treatment for Moderate to Severe Menopausal Hot Flashes Download image Noven Pharmaceuticals, Inc....
View ArticleNoven Pharmaceuticals, Inc. press release :Noven Enters Co-Promotion...
(Source: Hisamitsu Pharmaceutical Co Ltd) Noven Enters Co-Promotion Agreement with Shionogi for Brisdelle™ (Paroxetine) Capsules Co-Promotion to Extend Physician Awareness of the First and Only...
View ArticleNoven Pharmaceuticals Announces Issuance of New U.S. Patent, an Important...
Download image Noven Pharmaceuticals, Inc. (PRNewsFoto/Noven Pharmaceuticals, Inc.) MIAMI and NEW YORK, March 25, 2014 /PRNewswire/ -- Noven Pharmaceuticals, Inc. today announced the U.S. Patent and...
View ArticleWomen have more options for relieving menopausal symptoms
More than 15 years after Viagra hit the market and former Sen. Bob Dole brought the term "erectile dysfunction" into American living rooms, hot flashes and vaginal dryness - along with the other...
View ArticleNew drug treating hot flashes without hormones
The Food & Drug Administration (FDA) approved, today, the first for moderate to severe vasomotor symptoms (VMS) for women in menopause. Noven Pharmaceuticals has received approval for the use of...
View ArticleNoven Receives FDA Approval of a New Indication with a New Dose for...
MIAMI and NEW YORK, Sept. 24, 2014 /PRNewswire/ -- Noven Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication with a new dose of...
View ArticleNoven Pharmaceuticals, Inc. press release :Noven Receives FDA Approval of a...
(Source: Hisamitsu Pharmaceutical Co Ltd) Noven Receives FDA Approval of a New Indication with a New Dose for Minivelle® (Estradiol Transdermal System) Minivelle now approved for prevention of...
View ArticleFirst nonhormonal treatment for hot flashes, Brisdelle, approved by FDA
Women with uncomfortable hot flashes now have a medication option that doesn't involve hormones. The U.S. Food and Drug Administration approved the first nonhormonal drug to treat moderate to severe...
View ArticleNoven Announces Publication of Exploratory Analyses from Pooled Phase 3...
MIAMI and NEW YORK, Oct. 14, 2014 /PRNewswire/ -- Noven Pharmaceuticals, Inc., today announced the publication of data on the effects of low-dose mesylate salt of paroxetine (LDMP), marketed as...
View ArticleNoven Announces FDA Advisory Committee Vote on Investigational Low-Dose...
Tweet MIAMI, FL and NEW YORK, NY, March 4, 2013 /PRNewswire/ -- Noven Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) Reproductive Health Drugs Advisory Committee...
View ArticleNew Minivelle® (Estradiol Transdermal System) 0.025 mg/day Dose Now Available...
The new 0.025 mg/day dosage strength for Minivelle(R) (estradiol transdermal system) is now available in the US for the prevention of postmenopausal osteoporosis. Facebook Twitter Pinterest Noven...
View ArticleBARR PHARMACEUTICALS INCQuick Quote:
BRL 56.99 (+0.66) Duramed's ENJUVIA(TM) (Synthetic Conjugated Estrogens, B) Now Available in Pharmacies Nationwide 5/8/2006 --> Provides Menopausal Women A New Option In Treatment Of Vasomotor...
View ArticlePeople’s Pharmacy: Does Brisdelle work well for hot flashes?
Q: I saw a commercial for Brisdelle and wanted to know more, since I have struggled with hot flashes and night sweats for way too long. Then I learned it has the same ingredient as Paxil. I took Paxil...
View ArticleU.S. FDA Approves Lower Dose Formulation of ANGELIQ® (Drospirenone and...
, Feb. 29, 2012 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a lower dose formulation of ANGELIQ® (drospirenone...
View ArticleFDA approves first nonhormonal drug for hot flashes
Published July 01, 2013The Wall Street Journal The Food and Drug Administration Friday approved the first nonhormonal drug designed to treat hot flashes, one of the most bothersome symptoms of...
View ArticleNOVEN PHARMACEUTICALS Quick Quote:
--> Noven to Acquire JDS Pharmaceuticals, Expanding Business Model & Broadening Product Pipeline 7/10/2007 Acquisition Offers Self-Supporting Marketing & Sales Infrastructure Plus...
View ArticleNoven To Acquire Jds Pharmaceuticals, Expanding Business Model & Broadening...
07/19/2007 04:55:27 PM EDT Women's Health Weekly 2007 JUL 26 - (NewsRx.com) -- Noven Pharmaceuticals, Inc. (NASDAQ: NOVN) today announced that it has agreed to acquire JDS Pharmaceuticals, LLC for...
View ArticleNoven to Acquire JDS Pharmaceuticals, Expanding Business Model & Broadening...
07/10/2007 02:00:18 AM EDT Business Wire Infrastructure Plus High-Potential Late-Stage Product Pipeline Pharmaceutical Writers/Business Editors MIAMI--(BUSINESS WIRE)----Noven Pharmaceuticals, Inc....
View ArticleNoven Reports Positive Phase 2 Results for Mesafem(TM) Non-Hormonal Therapy...
MIAMI, Jul 14, 2009 (BUSINESS WIRE) -- Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) today announced positive top-line results from its Phase 2 clinical study evaluating Mesafem(TM) (low-dose paroxetine...
View ArticleNoven Completes Phase 3 Clinical Program for Investigational Non-Hormonal...
MIAMI & NEW YORK--(BUSINESS WIRE)--Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced that it has completed the Phase 3 clinical...
View ArticleNoven Announces Phase 3 Results for Investigational Non-Hormonal Therapy for...
MIAMI & NEW YORK--(BUSINESS WIRE)--Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced top-line results from the first of two planned Phase...
View ArticleNotification of the Noven Pharmaceuticals, Inc. assigns rights for Brisdelle®...
(Source: Hisamitsu Pharmaceutical Co Ltd) Microsoft Word - Brisdelle Pexeva譲渡_EN版_Noven確認済_20160726 This material is an English translation of the press release announced on July 26, 2016 in Japanese,...
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