FDA Approves Label Changes to Blood Pressure Medicine Olmesartan Medoxomil

The US Food and Drug Administration (FDA) is warning that the blood pressure drug olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy.

FDA Approves the First Non-Hormonal Treatment for Hot Flashes Associated with Menopause

The US Food and Drug Administration today approved Brisdelle (paroxetine) to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause.

FDA Approves First Recombinant Coagulation Factor IX

The US Food and Drug Administration yesterday approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older.

FDA Takes Action to Protect Consumers from Dangerous Medicines Sold by Illegal Online Pharmacies

The US Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers.

FDA Approves Vibativ

The US Food and Drug Administration today expanded the approved use of the antibiotic Vibativ (telavancin) to treat patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Staphylococcus aureus.

FDA Obtains Waiver from European Commission to Facilitate Export for US Pharmaceutical Manufacturers

The US Food and Drug Administration announced today that the US is now a “listed” country with the European Commission (EC) so that US companies need not obtain an export certificate from the FDA before shipping certain pharmaceutical products to Europe.

FDA Approves Plan B One-Step Emergency Contraceptive for Use Without a Prescription

Today, the US Food and Drug Administration announced it has approved the use of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential.

FDA Approves First Genotyping Test for Patients with Hepatitis C Virus

The US Food and Drug Administration today approved a test that identifies the genotype of hepatitis C virus (HCV) that a patient is carrying.

FDA Investigating Two Deaths Following Injection of Zyprexa Relprevv

The US Food and Drug Administration (FDA) is investigating two unexplained deaths in patients who received an intramuscular injection of the antipsychotic drug Zyprexa Relprevv (olanzapine pamoate).

FDA Approves new Silicone Gel-filled Breast Implant

The U.S. Food and Drug Administration today approved the MemoryShape Breast Implant to increase breast size (augmentation) for use in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.