FDA Alerts
FDA Approves Diclegis
The US Food and Drug Administration today approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) to treat pregnant women experiencing nausea and vomiting.
Rich Products Corporation Recalls Products for E. Coli Risk
Rich Products Corporation of Buffalo, New York, has announced a voluntary recall of certain Farm Rich ® and Market Day ® products.
Nicotine Replacement Therapy Labels May Change
When nicotine replacement therapy (NRT) products were first marketed almost 30 years ago to help people stop smoking, there wasn't a lot of data available on how long consumers could safely use them, and whether they could be used in combination with other NRTs or with continued smoking.
FDA Approves Invokana to Treat Type 2 Diabetes
The US Food and Drug Administration today approved Invokana (canaglifozin) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.
FDA Approves new Multiple Sclerosis Treatment
The US Food and Drug Administration today approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS).
FDA Approves First Botulism Antitoxin
The US Food and Drug Administration announced today that it has approved Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine) to treat patients showing signs of botulism following documented or suspected exposure to botulinum neurotoxin.
FDA Approves TOBI Podhaler
The US Food and Drug Administration today approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections.
FDA Issues Proposal to Improve the Quality of Automated External Defibrillators
The US Food and Drug Administration today issued a proposed order aimed at helping manufacturers improve the quality and reliability of automated external defibrillators (AEDs).
FDA Alerts Healthcare Providers and Patients of Nationwide Recall by Specialty Pharmacy
The US Food and Drug Administration is alerting healthcare providers and patients of a voluntary recall of all lots of sterile products produced and distributed by Clinical Specialties Compounding Pharmacy (CSCP) of Augusta, Ga.
FDA Approves Dotarem, a New Magnetic Resonance Imaging Agent
The US Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues in patients ages 2 years and older.