Tag Archives: Approves

FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications

South San Francisco, CA — April 12, 2021 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair (omalizumab) prefilled syringe for self-injection across all approved U.S. indications. Xolair is the only… Read More »

FDA Approves Qelbree (viloxazine) for the Treatment of ADHD

FDA Approves Qelbree (viloxazine) for the Treatment of ADHD ROCKVILLE, Md., April 02, 2021 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) approved Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity… Read More »

FDA Approves Roszet (rosuvastatin and ezetimibe) to Reduce LDL-C in Hyperlipidemia and Homozygous Familial Hypercholesterolemia

FDA Approves Roszet (rosuvastatin and ezetimibe) to Reduce LDL-C in Hyperlipidemia and Homozygous Familial Hypercholesterolemia Morristown, N.J. March 31, 2021 — Althera Pharmaceuticals, a company focused on heart health, today announced the FDA approval of Roszet (rosuvastatin and ezetimibe) tablets, as an adjunct to diet, for treatment of elevated low-density lipoprotein cholesterol (LDL-C) in adult… Read More »

FDA Approves New Indication & New Product Formulation for Myrbetriq for Use in Children with Neurogenic Detrusor Overactivity (NDO)

TOKYO, March 26, 2021 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) approved Myrbetriq (mirabegron extended-release tablets) for the treatment of NDO in pediatric patients aged three years and older who weigh 35 kg or more, and Myrbetriq Granules… Read More »

FDA Approves Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets for Colonoscopy Preparation

FDA Approves Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets for Colonoscopy Preparation BRAINTREE, Mass., Nov. 10, 2020 /PRNewswire/ — Sebela Pharmaceuticals® today announces that the U.S. Food and Drug Administration (FDA) approved Sutab® (sodium sulfate, magnesium sulfate, and potassium chloride) tablets. Sutab, a sulfate-based tablet preparation for colonoscopy, was developed and will be… Read More »

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis

FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis CARY, N.C., Nov. 02, 2020 (GLOBE NEWSWIRE) — Chiesi USA, Inc., the U.S. affiliate of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), received U.S. Food and Drug Administration (FDA) approval of Bronchitol (mannitol) inhalation powder. Bronchitol… Read More »