In the NDA resubmission, the Company included safety and efficacy data from the Phase 3 trial SECURE, the manufacturing information, and a summary response to the CRL.
The patient was a 32-year-old nulliparous white female who reported a 5-year history of severe hypertension, hypokalemia, and resultant systolic dysfunction.
Firstly, NAMS reiterates that HT should be individualized for each patient and requires periodic reevaluation for risks and benefits of selected therapy.
Cervical cap insemination has demonstrated a pregnancy success rate of up to 20%.
The study included information on 1,325,563 women enrolled in Medicaid. They gave birth between 2000 and 2010.
The analysis found that the simulated maternal serum concentration associated with the lowest probability of infant cerebral palsy was 4.1mg/dL, while the simulated total administered magnesium dose associated with the lowest probability of delivering an infant with cerebral palsy was 64g.
The data showed sarcopenia was 4 times more prevalent for the high-risk alcohol drinking group vs. the low-risk alcohol drinking group (odds ratio 4.29, 95% CI: 1.87, 9.82).
A review of recent data showed that insemination with sperm from an HIV-negative donor is the safest option for a discordant couple where the woman does not have HIV but the man is HIV-positive.
While IUD displacement has been discussed in the literature, the authors could not find a similar case which showed a displaced IUD reaching the diaphragm and causing chest pain.
Mibelas 24 Fe is an oral contraceptive indicated to prevent pregnancy in women who choose to use oral contraceptives.
The study was conducted in 1,000 women residing in the Republic of Ireland and Northern Ireland, where abortion is not available through the formal healthcare system.
The investigators found that earlier menopause was associated with increased risk of heart failure, and this link was stronger in women who had natural rather than surgical menopause.
Replens contains a blend of moisturizers and vitamins that help soothe and relieve symptoms such as irritation, discomfort, and chafing.
All 16 infants in the clinical trial of the device demonstrated a successful joining of their esophagus within 3-10 days after receiving it.
The FDA has issued a Complete Response Letter (CRL) to the New Drug Application (NDA) of TX-004HR (TherapeuticsMD) for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause.
In general, an increased risk of spontaneous abortion was seen with the use of macrolides (except erythromycin), quinolones, tetracyclines, sulfonamides, and metronidazole during early pregnancy.
Five lamb fetuses of 105 to 108 days of gestation were run for 25-28 days, and three fetuses of 115 to 120 days of gestation were run for 20-28 days.
Autism spectrum disorder was diagnosed by age 15 in 5.28% of exposed vs. 2.14% of unexposed babies; 12.63% of exposed vs. 5.46% of unexposed babies were diagnosed with ADHD by age 15.
The researchers found the associations of hot flashes to be independent of other cardiovascular disease risk factors.
"The findings highlight the likelihood that prenatal exposure to progesterone may have a long-term influence on behavior related to sexuality in humans," said lead researcher June Reinisch, Director Emerita of The Kinsey Institute.
TherapeuticsMD announced positive data for its investigational hormone therapy, TX-001HR, for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. Study findings were presented at the annual meeting of the Endocrine Society, ENDO 2017.
Information on vaccination, adverse pregnancy outcomes, and potential confounders were assessed for links in a cohort of women in Denmark.
What makes the technology ground-breaking is how it creates a dynamic culture in which organs communicate with each other as opposed to being static in a dish.
The researchers found that the overall survival was strongest among premenopausal women in the highest 25OHD tertile group.
Hypothalamic amenorrhea occurs when the hypothalamus slows or stops releasing GnRH, a hormone that controls the menstrual cycle. It can increase the risk of other health issues such as delayed puberty in adolescents and infertility in female adults.
The FDA has accepted and granted Priority Review to the New Drug Application (NDA) of Solosec (secnidazole oral granules; Symbiomix) for the treatment of bacterial vaginosis (BV).
Sales of prenatal supplements with DHA continue to rise, however little evidence exists on whether supplementation imparts a benefit on offspring neurodevelopment.
Researchers stated that there is a need for improved contraceptive access for teens, as proven by the increase in use of hormonal emergency contraceptives after the FDA approved the OTC availability under Plan B in 2012.
Embolization for uterine fibroids may be underused in U.S. hospitals, compared with surgery, according to research presented at the annual meeting of the Society of Interventional Radiology, held from March April 4 to 9 in Washington, D.C.
A study which assessed concentrations of certolizumab pegol (Cimzia; UCB) in human breast milk found that minimal to no transfer of drug from plasma to breast milk occurs.
Findings from a new study published in the journal Pharmacoepidemiology and Drug Safety indicate an increase in ondansetron use for the management of nausea among pregnant women from <1% in 2001 to 22.2% in 2014
Researchers found that their evidence showed no protective association between postmenopausal HT use and AD or dementia, although they observed a reduced AD risk among those with long-term self-reported HT use.
The investigators found that overall survival of periviable infants rose from 30% at the start of the research to 36% in the last time period
Even though Zika virus was found to linger for 3 months in semen, scientists say recommendations urging abstinence, condoms for 6 months after infection should still be followed.
The FDA have approved Tirosint-SOL, a liquid form of levothyroxine; a synthetic form of the thyroid hormone thyroxine.
A study published in the American Journal of Obstetrics & Gynecology reports that the total length of induced labor may be reduced with the use of glucose supplementation.
Chronic pain patients being treated with certain opioid and non-opioid medications had significantly lower serum concentrations of free testosterone (fTe) and free estradiol (fE2), highlighting the potential endocrinologic side effects of these drugs. These were the findings of a new study published in the journal Drug Testing and Analysis.
A fecal microbiota transplant through colonoscopy appears to be safe for recurrent Clostridium difficile infection during pregnancy, according to a case report published in the March issue of Obstetrics and Gynecology.
Prenatal exposure to bisphenol A (BPA) may raise a child's risk of obesity by altering hypothalamic circuits that regulate feeding behavior and energy balance, according to an experimental study published online Feb. 7 in Endocrinology.
In a study of female patients with epilepsy, retrospective data found that unintended pregnancy was common and varied by contraceptive type and antiepileptic drug (AED) stratification. Full findings are published in Neurology.
According to a new study published in The Journal of Clinical Endocrinology & Metabolism, preconception-initiated low-dose aspirin may help prevent pregnancy loss in women with high levels of C-reactive protein (CRP) who have previously lost a pregnancy.
Endoscopy during pregnancy is associated with increased risk of preterm birth or small for gestational age, according to a study published in the February issue of Gastroenterology.
The Food and Drug Administration has approved the marketing of the Seeker System (Baebies, Inc.) for the screening of four rare lysosomal storage disorders (LSDs) in newborns.
From 2002 to 2012 there was an increase in herb and supplement use among pregnant women, according to a research letter published in the American Journal of Obstetrics and Gynecology.
Licorice consumption during pregnancy has been linked to lower IQ, poorer memory, and attention deficit hyperactivity disorder (ADHD)-type problems in offspring.
Administration of azithromycin during labor is associated with a reduction in maternal and neonatal clinical infections, according to a study published online January 27 in Pediatrics.
Quality improvement initiatives, including provider education and feedback, can reduce the nulliparous term singleton vertex (NTSV) cesarean delivery rate, according to a study published in the February issue of The Joint Commission Journal on Quality and Patient Safety.
Peripartum exposure to synthetic oxytocin may increase the risk of postpartum depression or anxiety disorders. These are the findings of a new study published in the journal, Depression and Anxiety.
Strategies to help overweight or obese women limit their weight gain during pregnancy don't seem to alleviate the risk for obstetric complications, according to a study presented at the annual meeting of the Society for Maternal-Fetal Medicine, The Pregnancy Meeting.
Treatment of subclinical hypothyroidism in pregnancy may not always be the best option, according to a study published online Jan. 25 in The BMJ.
Parents of children with congenital heart disease (CHD) feel that survival statistics, surgeon-specific experience, and complication rates are the most important outcome measures for public reporting, according to a study presented at the annual meeting of the Society of Thoracic Surgeons, held from January 21 to 25 in Houston.
Gestational diabetes mellitus (GDM) may increase a first-time mother's risk of postpartum depression, and a history of maternal depression along with GDM further increases that risk, according to a study published online in Depression and Anxiety.
For HIV-infected women, anti-müllerian hormone is associated with age of menopause onset, according to a study published in the January issue of the American Journal of Obstetrics & Gynecology.
Magnetic resonance imaging (MRI) shortly after birth might help determine which premature babies have sustained a brain injury that will affect their development, according to a study published online in Neurology.
Symbiomix announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Solosec (secnidazole oral granules) for the treatment of bacterial vaginosis (BV).
For infants with Prader-Willi syndrome (PWS), oxytocin (OXT) administration is associated with improvement in feeding and social skills, according to a study published online January 18 in Pediatrics.
Allergan and Gedeon Richter announced positive results from the second Phase 3 trial of ulipristal acetate, evaluating its efficacy and safety for the treatment of abnormal bleeding due to uterine fibroids in women.
Among women at risk for preeclampsia, antiplatelet agents reduce the risk of spontaneous preterm birth at less than 37 and less than 34 weeks of gestation, according to a meta-analysis published in the February issue of Obstetrics & Gynecology.
A short interpregnancy interval after termination of pregnancy is associated with increased risk of preterm birth in subsequent birth, according to a study published in the February issue of Obstetrics & Gynecology.
A quality improvement initiative can reduce the number of human milk administration errors in the neonatal intensive care unit, according to a study published online in Pediatrics.
In a recommendation statement published in the Jan. 10 issue of the Journal of the American Medical Association, the U.S. Preventive Services Task Force (USPSTF) reaffirms that folic acid supplements reduce the risk of neural tube defects.
AMAG pharmaceuticals and Palatin Technologies have entered into an agreement for the exclusive North American rights to develop and commercialize Rekynda (bremelanotide), an investigational drug to treat hypoactive sexual desire disorder (HSDD).
Use of acid suppressing agents during pregnancy may increase the risk of asthma in the offspring, according to a study published in The Journal of Allergy and Clinical Immunology.
The American Thyroid Association (ATA) has released new evidence-based recommendations to guide clinicians in diagnosing and managing thyroid disease during pregnancy and the postpartum period.
Pyridoxine-doxylamine (Diclectin), used to manage the nausea and vomiting associated with morning sickness, may not be as effective as once believed, according to a new analysis published online in PLOS One.
For high-risk women, letrozole is more effective than aspirin for decreasing the incidence of moderate and severe early-onset ovarian hyperstimulation syndrome, according to a study published in the January issue of the American Journal of Obstetrics & Gynecology.
Allergan and Medicines360 announced that the Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) for Liletta (levonorgestrel-releasing intrauterine system).
The highest amounts of spending were seen with these 10 conditions.
Data from a large, 1-year postmarketing safety study conducted in Europe found that lactation at the time of insertion of an IUD/IUS was associated with an increased risk of perforation.
Data from a randomized, double-blind clinical study found that the use of pritelivir led to a lower percentage of swabs with herpes simplex virus (HSV) detection over 28 days vs. valacyclovir. Full findings from the study are published in JAMA.
In a study published in Diabetes Care, researchers reported that the absolute risk of thromboembolism among women with type 1 or type 2 diabetes using hormonal contraceptives was low.
The presence of a non-Lactobacillus-dominated microbiota in a receptive endometrium is associated with poor reproductive outcomes for women undergoing in vitro fertilization (IVF).
Since 1999, the FDA has been evaluating the potential adverse effects of general anesthetics and sedatives on children's brain development.
Data from the Birth Defects Study found that influenza vaccination coverage rose during the 2012-13 and 2013-14 season from 35% to 41%, respectively.
The Centers for Disease Control and Prevention (CDC) issued the final report on the Winnable Battles program which highlights public health priorities with large-scale impact on health and strategies that may help to address them.
Women with immune-mediated diseases receiving anti-tumor necrosis factor (TNF)-alpha agents had significantly higher risks of preterm birth, spontaneous abortion, and low birth weight vs. the general population, a study published in the Journal of Autoimmunity found.
Concerns about gaining weight may impact contraception choices for women.
The FDA has approved Intrarosa (prasterone; Endoceutics) for the treatment of women experiencing moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
The labeling now includes a new Boxed Warning and a Patient Decision Checklist.
The Food and Drug Administration (FDA) has approved Bonjesta (doxylamine succinate and pyridoxine HCl extended-release tablets; Duchesnay), a fixed-dose combination drug product for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.
Allergan announced the availability of Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, the first oral contraceptive in a softgel capsule for the prevention of pregnancy.
For women who are former hormone therapy users, risk of fracture is not increased after discontinuing therapy, according to a study published in the The Journal of Clinical Endocrinology & Metabolism.
Palatin has announced positive top-line results from the Phase 3 clinical trial of bremelanotide (a melanocortin 4 receptor agonist), an investigational treatment for hypoactive sexual desire disorder (HSDD).
BD announced that the Food and Drug Administration (FDA) has granted marketing clearance for BD MAX Vaginal Panel to detect the most common causes for vaginitis.
Pfizer announced a voluntary recall of one lot of Premarin (conjugated estrogens) 1.25mg tablets due to an incorrect expiration date applied to the bottle label.
A new study published online in the journal Contraception examines whether the risk of venous thromboembolism (VTE) and arterial thromboembolism (ATE) is increased in women using non-oral combined hormonal contraceptives compared to women using combined oral contraceptives (COC).
AbbVie has announced positive results from two replicate Phase 3 clinical trials of Elagolix in premenopausal women with endometriosis.
The Food and Drug Administration (FDA) reports the discontinuation of Menest (esterified estrogens; Pfizer) 2.5mg tablets.
A new study of over 56,000 women found that those who purchased antidepressants at least twice during pregnancy had a 37% increased risk of speech and/or language disorder in their offspring compared to mothers who were not treated with antidepressants.
Par announced a voluntary recall of certain lots of Gildess, Gildess FE, and Gildess 24 FE products.
Progestin-containing intrauterine device (IUD) was deemed safe and acceptable as a long-acting contraceptive for women with epilepsy, a study published in Epilepsia has found.
As regulatory status of levonorgestrel emergency contraception has changed over the years, there has been increased confusion about how emergency contraception can be sold.
For women with type 1 diabetes, elevated fatty acid binding protein 4 (FABP4) in early pregnancy and in the second trimester is associated with subsequent preeclampsia, according to a study published online September 14 in Diabetes Care.
The FDA has accepted for review the New Drug Application (NDA) for Yuvvexy (17β-estradiol; TherapeuticsMD) for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women.
Bayer announced that the Food and Drug Administration (FDA) has approved Kyleena (levonorgestrel-releasing intrauterine system) for the prevention of pregnancy for up to 5 years.
Data from a pilot randomized trial published in Nicotine & Tobacco Research showed that administering exogenous progesterone may potentially prevent postpartum smoking relapse.
The Food and Drug Administration (FDA) has issued a safety alert regarding the use of screening tests for ovarian cancer screening.
Ovarian cancer mortality is down dramatically in many parts of the world, and the use of oral contraceptives (OCs) may be a main reason why, according to a study published online in the Annals of Oncology.
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to SAGE-547 (Sage Therapeutics) for the treatment of postpartum depression (PPD).
Even though most new mothers in the United States begin breastfeeding their infants at birth, many stop sooner than recommended, according to the 2016 Breastfeeding Report Card from the U.S. Centers for Disease Control and Prevention.