United Health Products, Inc. which develops and markets products and technologies in the healthcare sector, today announced that its hemostatic gauze which is registered and branded in the USA under the trademark Hemostyp™ has received 510K approval from the FDA under the application and registration of its manufacturing agent. Hemostyp was originally introduced into the market in 2002 as a Class I exempt product for external wound care and dental applications.
An unscheduled inspection of an aseptic manufacturing process can hit a pharmaceutical company with the fury of a New England nor'easter. But a new management brief explains how a best-practice control and monitoring system can minimize the danger of FDA noncompliance. The brief is available for download from Microtest Laboratories.
The US Food and Drug Administration (FDA) has approved Afinitor (everolimus) tablets for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ breast cancer) in combination with exemestane after failure of treatment with letrozole or anastrozole.
Fitch Ratings expects the Food and Drug Administration (FDA) will approve fewer novel drugs in 2012 as compared to 2011 while the industry faces several ongoing operational risks, according to a new report.
The biopharmaceutical company Antisense Pharma GmbH announces that the US Food and Drug Administration (FDA) has granted Orphan Drug designation for its investigational oncology antisense compound trabedersen to treat malignant melanoma.
Previously, trabedersen has received Orphan Drug designation by the European EMA and the US FDA in high-grade glioma (malignant brain tumor) in 2002 and in advanced pancreatic cancer in 2009.
The media spotlight is often a double-edged sword. No one knows this better than people who filed a Wright Lawsuit. And yet, gossip and rumor-mongering aside, the real story here is being overlooked according to Sean Burke of AttorneyOne.
The U.S. Food and Drug Administration today approved Qsymia (phentermine and topiramate extended-release) as an addition to a reduced-calorie diet and exercise for chronic weight management.
The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).
Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Next Choice™ ONE DOSE (Levonorgestrel Tablet, 1.5 mg), the generic equivalent to Teva Women's Health's Plan B One-Step. Watson plans to launch the product immediately.
The U.S. Food and Drug Administration today issued a draft guidance that outlines the agency's recommendations and procedures for medical device manufacturers and researchers who want early feedback and advice before submitting a product- or research-specific application.
Perrigo Company announced that it has received final approval from the U.S.