Zuranolone: Novel, Rapid-Acting Antidepressant Awaits FDA Approval
A New Drug Application for zuranolone awaits FDA approval for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
FDA Accepts New Drug Application for Fezolinetant, A Novel Nonhormonal Treatment for Vasomotor Symptoms
The FDA accepted a New Drug Application for fezolinetant, a novel, nonhormonal selective neurokinin-3 receptor (NK3R) antagonist for the treatment of menopause-related vasomotor symptoms.
Essential Reads: The Pregnancy and Lactation Labeling Rule (PLLR)
The PLLR helps to put the potential effects of the drug into perspective with the goal of providing a more individualized risk-benefit analysis.
Sage Therapeutics and Biogen Announce Plans to Submit a New Drug Application for Zuranolone to the FDA in 2022
The FDA will review zuranolone for the treatment of depression in the first half of 2022.
How to Find Information on the Reproductive Safety of Medications
Last week, I met with a woman who was planning pregnancy. She had a long history of generalized anxiety disorder and panic disorder and had done very well over the past 10 years on [...]
Are Clinicians Using the PLLR to Guide Prescribing During Pregnancy?
In 2015, the U.S. Food and Drug Administration (FDA) proposed major revisions to prescription drug labeling -- the Pregnancy and Lactation Labeling Rule or PLLR -- in order to provide more accurate and helpful [...]
FDA is Expected to Approve Brexanolone for the Treatment of Postpartum Depression
In 2015, we first reported on SAGE-547 (SAGE Therapeutics), a new medication for the treatment of postpartum depression (PPD). Â SAGE-547, now called brexanolone, is an allosteric modulator of GABAA receptors. Â Since that time, Sage Therapeutics [...]
Another Medication for Pregnancy-Related Nausea and Vomiting
The US Food and Drug Administration (FDA) has approved another medication for the management of pregnancy-related nausea and vomiting. Â It is not really a new medication but is similar to Diclegis, a combination doxylamine succinate [...]
Taking a Look at the New FDA Pregnancy Labeling and Lactation Rule
The U.S. Food and Drug Administration (FDA) has proposed major revisions to prescription drug labeling in order to provide more accurate and helpful information on the effects of medications used during pregnancy and breastfeeding. The [...]
SSRI Antidepressants and PPHN: Much Lower Risk Than Previously Reported
In 2006, Chambers and colleagues published an article linking selective serotonin reuptake inhibitor (SSRI) antidepressant use during late pregnancy to an increased risk of persistent pulmonary hypertension in the newborn (PPHN). PPHN is a cardiovascular [...]