Tag Archives: Approves

FDA Approves Katerzia (amlodipine) Oral Suspension for Pediatric Patients 6 Years of Age and Older

FDA Approves Katerzia (amlodipine) Oral Suspension for Pediatric Patients 6 Years of Age and Older Print this page WOBURN, Mass. (July 10, 2019) – Azurity Pharmaceuticals, a specialty pharmaceutical company that makes safe, high-quality treatments for patients requiring customized formulations for their care, announced today that the U.S. Food and Drug Administration (FDA) has approved Katerzia (amlodipine)… Read More »

FDA Approves Broadened Indication for Xeomin (incobotulinumtoxinA) as First-Line Treatment for Blepharospasm (Involuntary Blinking) in Adult Patients

Print this page RALEIGH, N.C.  –  May 13,  2019  –  Merz Americas announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA), broadening its indication to be a first-line treatment of blepharospasm (involuntary blinking) in adult patients. “Merz is proud to offer a first-line… Read More »

FDA Approves New Treatments Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) for Heart Disease Caused by Transthyretin Mediated Amyloidosis

Print this page May 06, 2019 — On May 3, the U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. These are the first FDA-approved treatments for ATTR-CM. Vyndaqel and Vyndamax have the same active… Read More »