Tag food and drug administration

Catheter Connections Receives 510k Clearance From FDA For DualCap Vascular Access Disinfecting Cap

Jul29

Catheter Connections, Inc., a manufacturer of innovative vascular access and infection control products, announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its DualCap? product. DualCap is the only device that nests two disinfecting caps together – for both IV access points, the needleless injection site (NIS) [...]

Hospira to test generic anemia drug: Health care reform prompts interest in ‘biosimilar’ biotech drugs [Chicago Tribune]

Jul28

July 29In the wake of health reform’s passage into law, Hospira Inc. will begin testing a cheaper version of a popular anemia biotech treatment in the first phase of a U.S. clinical trial.Lake Forest-based Hospira said it will begin the first phase of trials for a "biosimilar," or a biogeneric, version of brand-name Epogen in [...]

AstraZeneca posts 22 per cent in Q2 profit, FDA committee approves blood thinner

Jul28

LONDON – AstraZeneca PLC has reported a 22 per cent rise in second quarter net profit and has also revealed that a key new drug – its blood thinner Brilinta – has been given a thumbs up by an advisory committee of the U.S. Food and Drug Administration.The Anglo-Swedish drugmaker on Thursday posted net profit [...]

Sanofi-Aventis warns on 2010 earns

Jul28

PARIS Sanofi-Aventis SA warned Thursday that its core earnings may fall up to 4 percent this year as a result of the U.S. Food and Drug Administration’s approval of a generic version of its Lovenox, an injected drug for preventing life-threatening blood clots.In a statement, the Paris-based drug maker says its so-called business net [...]

Abbott awarded FDA approval for two new dosage strengths of SIMCOR for cholesterol

Jul28

Health care company Abbott (NYSE:ABT) stated on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) for two new dosage strengths of SIMCOR (niacin extended-release / simvastatin), a cholesterol medication.The company claimed the new SIMCOR dosage strengths combine 40 mg of simvastatin, which is the most commonly prescribed dose of simvastatin, [...]

Bionovo to Advance Menerba to Phase 3 Clinical Testing in Europe

Jul28

EMERYVILLE, Calif., July 29 /PRNewswire-FirstCall/ Bionovo, Inc. (Nasdaq: BNVI) announced today that it has received final guidance from the European Medicines Agency (EMA) in order to advance Menerba, the company's lead drug candidate for menopausal symptoms, to Phase 3 clinical trials in Europe. The guidance defines the clinical and regulatory pathway to a European [...]

Endologix Receives FDA Approval for PowerFit Aortic Extensions

Jul28

IRVINE, Calif., July 29 /PRNewswire-FirstCall/ Endologix, Inc. (Nasdaq: ELGX), developer of minimally invasive treatments for aortic disorders, announced today that it has received U.S. Food and Drug Administration (FDA) approval for its new PowerFit? Aortic Extensions. The PowerFit extensions are designed to provide physicians with enhanced visibility under fluoroscopy to facilitate precise device placement [...]

Endologix says FDA approves new stent

Jul28

IRVINE, Calif. Medical device maker Endologix Inc. said Thursday it received Food and Drug Administration approval for its PowerFit Aortic Extensions stent.Stents are mesh-wire tubes that are used to prop arteries open after they have been surgically cleared of fatty plaque. The device is used in surgery to repair abdominal aortic aneurysms.Shares of Endologix [...]

SD to get $155,000 in drug company settlement

Jul28

PIERRE, S.D. Attorney General Marty Jackley says South Dakota will receive about $155,000 from a national settlement with a subsidiary of pharmaceutical manufacturer Johnson & Johnson over allegations the company illegally marketed an anti-seizure drug.The settlement states that the subsidiary, Ortho-McNeil-Janssen Pharmaceuticals, schemed to improperly market the drug Topamax for uses not approved by [...]

Reports from Children’s Hospital highlight recent research in dermatology

Jul27

Researchers detail in ‘Avagard hand antisepsis vs. traditional scrub in 3600 pediatric urologic procedures,’ new data in dermatology. According to recent research from the United States, "Avagard is a waterless, scrubless, and brushless hand antiseptic approved by the Food and Drug Administration as a replacement for traditional presurgical brush hand scrubbing. We evaluated the use [...]

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