FDA Approves Drug to Reduce Risk of Heart Attack
April 29th 2019High levels of ‘bad’ cholesterol, also known as low-density lipoprotein cholesterol (LDL-C), increase patients' risk for serious CV events such as heart attack or stroke. Adults who experience a heart attack or stroke have an approximately 1 in t3 chance to have another CV event.
FDA Approves Pediatric Lupus Treatment
April 26th 2019This is the first time that the FDA has approved a treatment for pediatric patients with SLE. Belimumab has been approved for use in adult patients since 2011. GSK’s application for belimumab use in pediatric patients was granted the FDA’s Priority Review designation.
35 Lots of Bulk Losartan Potassium Tablets Recalled
April 26th 2019This recall was initiated by detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – found in 6 lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the FDA’s interim acceptable exposure limit of 9.82 ppm.
Veterans with HIV May Have Higher Risk of Death Associated with Depression
April 19th 2019Investigators from the Boston University School of Medicine (BUSM) used data from participants of the Veteran’s Aging Cohort Study to compare the risk of death among US veterans who were depressed to those not suffering from depression.
FDA Warns Against Use of Unapproved Medical Devices to Help Assess or Diagnose a Concussion
April 10th 2019The FDA warned that such tools, including mobile apps marketed to coaches or parents for use during sporting events, have not been reviewed by the agency for safety and efficacy and could result in an incorrect diagnosis.
FDA: NDA for Diabetic Gastroparesis Treatment Rejected in Current Form
April 3rd 2019The FDA will not issue a new drug application (NDA) for the recurrent diabetic gastroparesis medication Gimoti in the application's present form, but they have issued recommendations to address the 2 remaining approvability issues, related to clinical pharmacoogy and product quality, in the NDA resubmission.
Possible Link Between Seizure and E-Cigarette Use Under FDA Investigation
April 3rd 2019According to the FDA, seizures are known potential adverse effects of nicotine poisoning and have been reported in scientific literature in relation to intentional or accidental swallowing of nicotine-containing e-liquids.