Posts Tagged ‘FDA’

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October 31st, 2014

FDA Advisory Panel Gives Tepid Support to New Anticoagulant

On Thursday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-1 in favor of approval for Daiichi Sankyo’s edoxaban (Savaysa). The outcome will likely result in a drug that will be on the market, but that few physicians will prescribe until further studies are performed. Edoxaban will almost certainly become the fourth new oral anticoagulant (NOAC) to […]


October 13th, 2014

First Drug-Coated Balloon Approved by FDA for Leg Blockages

The FDA today announced that it had approved for use in the U.S. the first drug-coated angioplasty balloon catheter to re-open blocked arteries in the superficial femoral and popliteal arteries. The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) is manufactured by CR Bard and has been available in Europe since 2012. “Peripheral artery disease can be quite serious. Preventing […]


September 18th, 2014

FDA Approves New Once-Weekly GLP-1 Receptor Agonist for Type 2 Diabetes

The FDA said today that it had approved dulaglutide, Lilly’s once-weekly injection to control blood sugar in adults with type 2 diabetes. The drug will be marketed under the brand name of Trulicity. The FDA said that the safety and efficacy of dulaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, had been studied in  3,342 type 2 diabetics. The drug […]


September 11th, 2014

FDA Approves New Weight Loss Drug

The FDA announced today that it had approved Contrave, the long-awaited and much-disputed weight loss drug.  Contrave is a combination of two drugs already approved for other indications: naltrexone hydrochloride, which is used to combat alcohol and opioid dependence, and bupropion, which is used to treat depression and seasonal affective disorder and as an aid to smoking cessation treatment. […]


September 10th, 2014

FDA Advisory Panel Offers Cautious Support for Polypill

The controversial polypill took one step closer to reaching the U.S. market after receiving a mostly positive reception from the FDA’s Cardiovascular and Renal Drugs Advisory Committee on Wednesday. The idea for the polypill– which in this case would be composed of aspirin, a statin, and one or more blood pressure drugs– has been kicking around for […]


August 21st, 2014

FDA Grants Apixaban Expanded Indication for Venous Thromboembolism

The FDA today approved an expanded indication for the oral anticoagulant apixaban (Eliquis, Bristol-Myers Squibb and Pfizer). Apixaban will now be indicated for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE (collectively known as venous thromboembolism) after initial therapy. The supplemental new […]


June 25th, 2014

FDA Completes Safety Review of Olmesartan

The FDA announced on Tuesday that it had completed its safety review of the antihypertensive drug olmesartan (sold as Benicar and other names). The investigation was initiated in 2010 when results from the ROADMAP trial showed that patients with type 2 diabetes taking olmesartan had an increased risk for cardiovascular death. Now the FDA says that […]


June 24th, 2014

FDA Recalls Another Batch of Generic Metoprolol

The FDA has recalled more than 13,000 bottles of metoprolol succinate extended-release tablets manufactured by Dr. Reddy’s Laboratories. In addition, the agency recently recalled another lot of generic metoprolol from a different company, Wockhardt. Both recalls were for medicines manufactured at facilities in India. There have been multiple reports in recent years of problems with generic […]


June 18th, 2014

Yet Another Delay for Boston Scientific’s Watchman Device

Boston Scientific hopes the third time will be the charm. The company disclosed on Tuesday yet another obstacle in the path to approval for its novel Watchman left atrial appendage closure device for the prevention of stroke in patients with atrial fibrillation. Although it has already been before two FDA advisory panels, the company said […]


June 13th, 2014

FDA Advisory Panel Supports Novel Drug-Coated Balloon

The FDA’s Circulatory System Devices advisory panel voted unanimously on Thursday to support approval of CR Bard’s Lutonix Drug-Coated Balloon (DCB). It would be used to enlarge arteries in a subset of patients who have peripheral arterial disease — including obstructive de novo or nonstented restenotic lesions (≤ 15 cm in length) in native femoropopliteal arteries […]