News Releases
U.S. Marshals Seize More than $2 Million in Adulterated Dietary Supplements from Georgia Company
At the request of the US Food and Drug Administration, US Marshals seized dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, Inc., located in Norcross, Ga., after FDA investigators found the products contained 1,3-Dimethylamylamine HCl (DMAA) or its chemical equivalent.
FDA Approves Gazyva for Chronic Lymphocytic Leukemia
The US Food and Drug Administration today approved Gazyva ( obinutuzumab ) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).
FDA Approves Label Changes for Anti-Seizure Drug Potiga
The US Food and Drug Administration (FDA) has approved changes to the drug label of the anti-seizure drug Potiga ( ezogabine ), underscoring risks of abnormalities to the retina in the eye, potential vision loss, and skin discoloration, all of which may become permanent.
FDA Approves Second Brain Imaging Rx for Alzheimer’s Disease, Dementia Evaluation
The US Food and Drug Administration today approved Vizamyl ( flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer's disease (AD) and dementia.
FDA Approves Extended-Release, Single-Entity Hydrocodone Product
The US Food and Drug Administration today approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.
FDA Advisory Committee Recommends Approval in US of Umeclidinium/Vilanterol
GlaxoSmithKline plc and Theravance, Inc. today announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) voted 11 yes to 2 no that the efficacy and safety data provide substantial evidence to support approval of umeclidinium/vilanterol (UMEC/VI, 62.5/25 mcg dose) for the long-term, once-daily, maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Health Canada Endorsed Important Safety Information on Sutent (sunitinib malate) Capsules
Pfizer Canada Inc. (manufacturer of Sutent), in collaboration with Health Canada, would like to inform you about an important revision to the Product Monograph, including the consumer information section, for Sutent (sunitinib malate).
Digital Health And The Pharmacy: A Prescription For Success
Much has been written about the emergence of digital health, the changing role of the physician and the more active role that patients will be taking in care.
MannKind Reports Positive Data from a Phase 3 Clinical Study of Afrezza in Patients with Type 1 Diabetes
MannKind Corporation today announced positive preliminary results from Study 171, a Phase 3 clinical study of AFREZZA® (insulin human [rDNA origin]) Inhalation Powder, an investigational, ultra rapid-acting mealtime insulin therapy, administered using MannKind’s next-generation (Gen2) inhaler, in patients with type 1 diabetes.
Forest Laboratories and Pierre Fabre Laboratories Announce FDA Approval of FETZIMA
Forest Laboratories, Inc. and Pierre Fabre Laboratories announced today that FETZIMA™ (levomilnacipran extended-release capsules), a once-daily serotonin and norepinephrine reuptake inhibitor (SNRI), discovered by Pierre Fabre Laboratories and co-developed by Forest Laboratories, Inc. was approved by the US Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD) in adults.