In an effort to lessen the impact drug shortages have on public health, FDA has published a strategic plan to improve the agency’s response to imminent or existing shortages and to develop longer-term approaches for addressing the underlying causes of such shortages, the agency reported on its Web site.
FDA has finalized its Unique Device Identification (UDI) regulation intended to drive consistency in medical device identification. The final rule requires that most medical devices distributed in the United States bear a unique device identifier, the agency posted on its UDI page today.
Tris Pharma, a specialty pharmaceutical company focused on developing innovative drug delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Karbinal™ ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg/5ml, the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial allergic rhinitis in children ages 2 and up.
Merck, known as MSD outside the United States and Canada, today announced that the Biologics License Application (BLA) for its investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) has been accepted for review by the U.S. Food and Drug Administration (FDA). In March, the company also submitted a BLA to the FDA for its investigational ragweed pollen (Ambrosia artemisiifolia) AIT.
Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved ACIPHEX Sprinkle Delayed-Release Capsules 5mg and 10mg for the treatment of Gastroesophageal Reflux Disease (GERD) in children 1 to 11 years of age for up to 12 weeks.
X-spine, a global leader in the design and manufacture of devices for the treatment of spinal disease, announces a new USFDA clearance for the Silex sacroiliac (SI) joint fusion system.