The approval was based on data from 2 multinational double-blind, placebo-controlled Phase 3 trials involving 1686 premenopausal women with moderate to severe pain associated with endometriosis.
Elagolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, was evaluated in two Phase 3 clinical studies in about 1,700 women with moderate-to-severe endometriosis-associated pain.
Menstrual abnormalities, endometriosis, pelvic pain, hysterectomy, and early/surgical menopause are all associated with chronic fatigue syndrome (CFS), according to new research.
Teva, Mylan, Actavis, and Lupin announced the launch of Celecoxib Capsules, the generic version of Pfizer's Celebrex.
Breckenridge announced the launch of Mefenamic Acid 250mg capsules, the generic version of Shionogi's Ponstel.
The FDA has granted approval for the first generic versions of Celebrex (celecoxib; Pfizer) capsules.
Bleeding disorders play an important role in both explained and unexplained cases of heavy menstrual bleeding due in many cases to low but not deficient factor XI levels.
Pfizer Consumer Healthcare announced the availability of its latest fast acting pain relief medication, Advil (ibuprofen sodium) Film Coated tablets.
Treatment with cholecalciferol, which rapidly enhances 25-hydroxyvitamin D3 (25[OH]D), is associated with decreased pain and reduced nonsteroidal anti-inflammatory drug (NSAID) use for women with primary dysmenorrhea.
Pfizer Consumer Healthcare announced a voluntary recall of one lot of ThermaCare HeatWraps Menstrual product after a potential leak of the components contained in the wrap was found.
Ferring Pharmaceuticals has launched Lysteda (tranexamic acid tablets) for the treatment of cyclic heavy menstrual bleeding (HMB) in women.