FDA Approves Imvexxy for Moderate to Severe Dyspareunia FDA Approves Imvexxy for Moderate to Severe Dyspareunia
The FDA approved estradiol vaginal inserts (Imvexxy, TherapeuticsMD) for moderate to severe dyspareunia.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - May 31, 2018 Category: Consumer Health News Tags: Ob/Gyn & Women ' s Health News Alert Source Type: news
Hormone therapy may slow cognitive decline
A combination therapy of estradiol and progesterone may benefit cognitive function in postmenopausal women, a study inMenopause suggests.Science Daily (Source: Society for Endocrinology)
Source: Society for Endocrinology - May 31, 2018 Category: Endocrinology Source Type: news
TherapeuticsMD Announces FDA Approval of Imvexxy (estradiol vaginal inserts) for the Treatment of Dyspareunia Due to Menopause
BOCA RATON, Fla., May 30, 2018 /PRNewswire/ -- TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women ' s healthcare company, today announced that the United States Food and Drug Administration (FDA) has approved Imvexxy (estradiol vaginal inserts)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 31, 2018 Category: Drugs & Pharmacology Source Type: news
On second try, TherapeuticsMD lands FDA nod for vaginal capsule
TherapeuticsMD (NSDQ:TXMD) said today that it won FDA approval for its applicator-free estradiol vaginal capsule, TX-004HR.
The soft-gel capsule is designed to treat moderate-to-severe vaginal pain experienced during sex, a symptom of vulvar and vaginal atrophy in women who have undergone menopause.
Get the full story at our sister site, Drug Delivery Business News.
The post On second try, TherapeuticsMD lands FDA nod for vaginal capsule appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - May 30, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Women's Health TherapeuticsMD Source Type: news
Hormone Levels After Menopause Tied to Heart Risks (CME/CE)
(MedPage Today) -- Higher testosterone/estradiol ratio associated with CVD, CHD, and HF (Source: MedPage Today Endocrinology)
Source: MedPage Today Endocrinology - May 29, 2018 Category: Endocrinology Source Type: news
Allergan Issues Nationwide Voluntary Recall of TAYTULLA ® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules
Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA ® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample p ack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules. (Source: Food and Drug Administration)
Source: Food and Drug Administration - May 29, 2018 Category: Food Science Source Type: news
Allergan Issues Nationwide Voluntary Recall of TAYTULLA ® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules
Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA ® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules. (Source: Food and Drug Administration)
Source: Food and Drug Administration - May 29, 2018 Category: Food Science Source Type: news
Osteoporosis Spinal Fractures; Vaginal Estradiol Tx; Diabetic Dog Lawsuit?
(MedPage Today) -- News and commentary from the endocrinology world (Source: MedPage Today OB/GYN)
Source: MedPage Today OB/GYN - May 11, 2018 Category: OBGYN Source Type: news
Low - Dose Vaginal Estradiol Improves Menopause - Linked QOL
Significant improvement in total MENQOL scores, MENQOL sexual function domain for vaginal estradiol (Source: The Doctors Lounge - Psychiatry)
Source: The Doctors Lounge - Psychiatry - May 10, 2018 Category: Psychiatry Tags: Family Medicine, Gynecology, Internal Medicine, Pharmacy, Psychiatry, Journal, Source Type: news
Low-Dose Vaginal Estradiol Improves Menopause-Linked QOL
THURSDAY, May 10, 2018 -- For menopausal women with moderate-severe vulvovaginal symptoms, treatment with low-dose vaginal estradiol is associated with improved menopause-related quality of life, according to a study published online May 7 in... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 10, 2018 Category: Pharmaceuticals Source Type: news
Vaginal estradiol tablets outperform moisturizers when treating vulvovaginal problems
(The North American Menopause Society (NAMS)) Sex shouldn't hurt at any age, yet 75 percent of postmenopausal women report vaginal dryness, and up to 40 percent report pain with intercourse. A new study reports that vaginal estradiol tablets just might be what's needed to relieve vulvovaginal problems and improve overall quality of life. Study results are published online today in Menopause, the journal of The North American Menopause Society (NAMS). (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - May 9, 2018 Category: International Medicine & Public Health Source Type: news
Lo-Zumandimine (Drospirenone and Ethinyl Estradiol Tablets) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - April 19, 2018 Category: Drugs & Pharmacology Source Type: news
TherapeuticsMD negotiates label for vaginal capsule after NDA resubmission
TherapeuticsMD (NSDQ:TXMD) is negotiating with the FDA over the proposed label for its investigational, applicator-free estradiol vaginal capsule, TX-004HR, the company reported today.
The softgel capsule is designed to treat moderate-to-severe vaginal pain experienced during sex, a symptom of vulvar and vaginal atrophy in women who have undergone menopause.
Get the full story at our sister site, Drug Delivery Business News.
The post TherapeuticsMD negotiates label for vaginal capsule after NDA resubmission appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - April 11, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Women's Health TherapeuticsMD Source Type: news
Impax Launches a Generic Version of Estrace(R) Cream (estradiol vaginal cream, USP, 0.01%)
BRIDGEWATER, N.J., April 6, 2018 -- (Healthcare Sales & Marketing Network) -- Impax Laboratories, Inc. (NASDAQ: IPXL), a specialty pharmaceutical company, today announced it has launched a generic version of Estrace® Cream (estradiol vaginal cream, US... Biopharmaceuticals, Generic, Product Launch Impax Laboratories, Perrigo Company, Estrace Cream, estradiol vaginal cream (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 6, 2018 Category: Pharmaceuticals Source Type: news
Vaginal Estradiol Offers Little Help for Postmenopausal Symptoms
(MedPage Today) -- Moisturizer no better than placebo gel, either (Source: MedPage Today OB/GYN)
Source: MedPage Today OB/GYN - March 19, 2018 Category: OBGYN Source Type: news
