The U.S. Food and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease, on Monday, July 11, 2016. Xiidra® is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) antagonist, approved by […]
The U.S. Food and Drug Administration (FDA) has approved an over-the-counter retinoid drug for acne — the first new active ingredient available without a prescription since the 1980s.
The drug named Differin Gel 0.1% (adapalene)- has been in use in a stronger form as a prescription acne treatment […]
In its July 8 update, the Centers for Disease Control and Prevention (CDC) advised against treating any patient with oral liquid docusate products. According to the CDC 47 Burkholderia cepacia complex (also known as “B. cepacia complex”) cases have been confirmed by molecular typing to match one […]
FDA MedWatch Announces Safety Labeling Changes posting includes 86 products with changes to Prescribing Information
The FDA MedWatch May 2016 Safety Labeling Changes posting includes 86 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE. Changes to the official labeling of drugs licensed for use by the FDA in the Unites […]
The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new – guidance for 340B Drug Pricing Program (340B Program) covered […]
The FDA recently (5/12/2016) published an advisory via their Drug Safety Communication Program regarding the routine use of fluoroquinolone antibacterials for non-life threatening infections such as sinusitis, bronchitis and uncomplicated urinary tract infections (uUTI) due to serious adverse effects that may cause “disabling and potentially permanent serious side effects” […]