Tag Archives: Approves

FDA Approves Spravato (esketamine) Nasal Spray for Treatment-Resistant Depression

Print this page March 5, 2019 — The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). Because of the risk of serious adverse outcomes resulting… Read More »

FDA Approves Adhansia XR (methylphenidate hydrochloride) Extended-Release Capsules for the Treatment of ADHD

FDA Approves Adhansia XR (methylphenidate hydrochloride) Extended-Release Capsules for the Treatment of ADHD Print this page STAMFORD, Conn.–(BUSINESS WIRE) March 01, 2019 –Adlon Therapeutics L.P., a subsidiary of Purdue Pharma L.P., announced that the U.S. Food and Drug Administration (FDA) approved Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII, a central nervous system (CNS) stimulant, for… Read More »

FDA Approves New Children’s Vaccine

Dec. 28, 2018 — The FDA has approved a new vaccine to immunize children against diphtheria, tetanus, pertussis (also known as whooping cough), hepatitis B, polio, and an invasive disease caused by Haemophilus influenzae type b, sometimes known as Hib. The vaccine will be for children 6 weeks to 4 years old. All will require… Read More »

FDA Approves Motegrity (prucalopride) for Adults with Chronic Idiopathic Constipation (CIC)

FDA Approves Motegrity (prucalopride) for Adults with Chronic Idiopathic Constipation (CIC) Print this page Cambridge, Mass. – December 17, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG) has announced that the U.S. Food and Drug Administration (FDA) has approved Motegrity™ (prucalopride), a once-daily, oral treatment option for adults with Chronic Idiopathic Constipation (CIC).1 Motegrity, a… Read More »

FDA Approves Aemcolo (rifamycin) to Treat Travelers’ Diarrhea

FDA Approves Aemcolo (rifamycin) to Treat Travelers’ Diarrhea Print this page November 16, 2018 — The U.S. Food and Drug Administration today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the… Read More »