FDA approves for launch of Therapeutics MD's BIJUVA ™ capsule (1 mg/100 mg)

as the ovaries stop producing hormones and circulating estrogen levels drop, they often develop symptoms of tube aureus (VMS, also known as hot/tidal), as well as sleep and mood disorders and urinary system problemshot flashes (including night sweats) are the most common symptoms, with 80% of women affected by the effects, which can debilitate people and last for several years after menopauseDespite these symptoms of trouble, many women do not seek treatmentOctober 29, Therapeutics MD announced that the U.SFDA(approved its BIJUVA ™ (1 mg/100 mg) capsules (1 mg/100 mg), the first and only FDA-approved combination of therapies containing biologically identical hormones (estradiol and progesterone) in a single oral capsule to treat moderate to severe vagiossis symptoms caused by menopause in women, often referred to as "tidal or red."this approval is based on BIJUVA's clinical development program, which includes the critical Clinical Phase III SupplementalTrial(assessing the safety and efficacy of the drug inhealth(in postmenopausal women) used to treat moderate to severe flash feverin line with FDA guidelines, the common primary therapeutic endpoint in this supplementary trial is a change in the value and severity of hot flashes in the 4th and 12th weeks in comparison to placeboThe main safety endpoint is the incidence of endometriosis during treatment lasting up to 12 monthscompared to placebo, BIJUVA showed a statistically significant decrease in the frequency and severity of hot flashes from baseline, while also reducing the risk of endometrial diseaseThe most common adverse reactions inare breast swelling, headache, vaginal bleeding, vaginal discharge and pelvic painIn addition, there were no significant clinical changes in lipid, clotting, or glucose parameters compared to placeboThere are no unexpected safety signals