FDA

U.S. Senator Orrin Hatch (R-Utah), Ranking Member of the Committee on Finance, today announced an amendment to S. 3187, the Food and Drug Administration Safety and Innovation Act, to repeal the job-killing medical device tax that was included in the $2.6 trillion health spending law enacted last year.

Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee has voted against the approval of XARELTO (rivaroxaban), an oral anticoagulant, to reduce the risk of secondary cardiovascular events in patients with Acute Coronary Syndrome (ACS) in combination with standard antiplatelet therapy.

New research sponsored by CVS Caremark examined the effects of Food and Drug Administration (FDA) drug warnings on medication adherence when the warnings are not delivered with clear clinical recommendations. The research found that immediately following a high-profile FDA communication questioning the efficacy for a cholesterol-lowering drug, the monthly level of patients who stopped filling their prescription increased by nearly 6 percent.

While a new report from the Government Accountability Office (GAO) shows that the Food and Drug Administration (FDA) has become more efficient in terms of its overall processing and reviewing applications, it also found that three of the five consumer advocacy group stakeholders that GAO researchers spoke with raised issues about whether FDA is adequately ensuring the safety and efficacy of the drugs it approves for marketing.

Acella Pharmaceuticals, LLC, a specialty pharmaceutical company, announces the approval of an Abbreviated New Drug Application (ANDA) for Gabapentin Oral Solution, 250 mg/5 mL. The Food and Drug Administration (FDA) determined that Acella's ANDA is bioequivalent – therefore, therapeutically equivalent – to the reference listed drug, Neurontin Oral Solution, 250 mg/5 mL.

Organizers of the Medical Design and Manufacturing (MD&M) East Conference have announced sixteen focused sessions will be held at the Pennsylvania Convention Center, May 21 - 24, 2012. The conference is part of the East Coast's largest annual event dedicated to medical design and manufacturing professionals, featuring presentations from close to one hundred medical technology professionals and FDA representatives. Supporting organizations include FDA, ASQ, and SPE.

Brussels, Belgium-UCB announced today that the U.S. Food and Drug Administration (FDA) approved Neupro (rotigotine transdermal system) for the treatment of the signs and symptoms of advanced stage idiopathic Parkinson's disease (PD) and as a treatment for moderate-to-severe primary Restless Legs Syndrome (RLS).

AstraZeneca announced that on March 7, the Food and Drug Administration (FDA) denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labeling that omits certain hyperglycemia warning language that the FDA required AstraZeneca to include in the labeling for Seroquel (quetiapine fumarate) tablets and Seroquel XR (quetiapine fumarate) extended-release tablets.

AstraZeneca said it is evaluating the FDA's decision and reasoning.

PRODUCT / LOT NUMBER:
GAMMAGARD LIQUID, [Immune Globulin Intravenous (Human)] 10%, 20g size
Product Code 1502797
NDC # 0944-2700-06
 
MANUFACTURER:
Baxter Healthcare Corp.
Westlake Village, CA
 
REASON:

Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced today by the U.S. Food and Drug Administration.