The U.S. Food and Drug Administration today approved the 4 milligram maximum dose of Livalo (pitavastatin), a drug intended to improve blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels. [More]

The US Food and Drug Administration (FDA) has now approved Lipsovir, i.e. granted Medivir's New Drug Application (NDA) for the use of acyclovir and hydrocortisone for early treatment of recurrent cold sores to decreases the risk of cold sores, and to shorten the healing time for those cold sores which are not prevented. [More]

The U.S. Food and Drug Administration today approved Invega Sustenna (paliperidone palmitate) extended-release injectable suspension for the acute and maintenance treatment of schizophrenia in adults. [More]

The U.S. Food and Drug Administration has approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels. [More]

Mylan Inc. has announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for Haloperidol Tablets USP, 10 mg and 20 mg. These strengths are in addition to Mylan's currently marketed 0.5 mg, 1 mg, 2 mg and 5 mg strengths of the product. [More]

Mylan Inc. has announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Liothyronine Sodium Tablets USP, 5 mcg (base), 25 mcg (base) and 50 mcg (base). [More]

Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) has approved Multaq (dronedarone) 400 mg Tablets. Patients with atrial fibrillation (AF) or atrial flutter (AFL) soon will have a new treatment option to help improve current management of their disease. Multaq is the first drug approved in the United States that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with AF/AFL. [More]

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the New Drug Application (NDA) for exenatide once weekly has been accepted for review by the U.S. Food and Drug Administration (FDA). [More]

Shire plc has announced that, at the request of the FDA, in view of a potential restriction on the availability of the current approved and marketed treatment for Gaucher’s disease patients, it has filed a treatment protocol for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Gaucher’s disease. [More]

The Associated Press reports that FDA Commissioner Margaret Hamburg "announced Tuesday she has created a task force to make recommendations on how the agency can release more information in such areas as drug evaluation and enforcement matters. She wants a report in six months." [More]

Patients can expect significant savings and better outcomes from their prescription medications when health care professionals use comparative effectiveness research, according to researchers at the University of Illinois at Chicago. [More]

Patients and physicians "need to know not just whether a new drug outperforms a placebo, but whether it's a real advance on what's already on the market," Richard Friedman, a professor of psychiatry at Weill Cornell Medical College, writes in a New York Times opinion piece. [More]

A.P. Pharma, Inc. has announced that it has submitted a New Drug Application (NDA) for its lead product, APF530, to the U.S. Food and Drug Administration (FDA). APF530 is being developed for the prevention of chemotherapy-induced nausea and vomiting (CINV) and is a long-acting formulation of granisetron that utilizes the Company's proprietary Biochronomer drug delivery system. [More]

A large, well-controlled, multi-national clinical trial program has demonstrated the effectiveness and safety of what may become the first FDA-approved medicine for idiopathic pulmonary fibrosis, or IPF. [More]

Pharmaxis has announced it had received notification from the United States Food and Drug Administration (FDA) that the New Drug Application (NDA) for its mannitol bronchial challenge test Aridol has been accepted for standard review. The FDA will advise the result of the review on 27 December 2009. [More]