Boston Scientific Corporation today announced that it has received 510 clearance from the U.S. Food and Drug Administration and CE Mark approval to market its WallFlex Fully Covered Esophageal Stent for the treatment of malignant esophageal strictures caused by tumors in patients with resectable or non-resectable esophageal cancer.
Revatio is the Only Treatment in Its Class with Both Oral and Intravenous Formulations. Pfizer announced today that the U.S. Food and Drug Administration has approved Revatio Injection, an intravenous formulation of Revatio. Revatio is indicated for the treatment of adult patients with pulmonary arterial hypertension to improve exercise ability and
Guidance for Industry on Changes to Approved New Animal Drug ApplicationsNew Animal Drug Applications Versus Category II Supplemental New Animal Drug Applications; Availability. SUMMARY: The Food and Drug Administration is announcing the availability of a guidance for industry #191 entitled "Changes to Approved NADAsNew NADAs vs.
Astellas Pharma Inc. and XenoPort, Inc. today announced that a new drug application has been filed with the Pharmaceuticals and Medical Device Agency in Japan for ASP8825, also known as XP13512, as a potential treatment for restless legs syndrome. "We are pleased to submit the NDA for ASP8825 in Japan," said Masafumi Nogimori, Astellas' president a
19 November 2009 - Endologix Inc, a US-based maker of minimally invasive treatments for aortic disorders, said yesterday it has obtained Investigational Device Exemption conditional approval from the US Food and Drug Administration to start a study for a bilateral percutaneous approach to endovascular abdominal aortic aneurysm repair utilising its
Shire plc, the global specialty biopharmaceutical company, announced that the United States Food and Drug Administration has granted Priority Review for the New Drug Application for velaglucerase alfa, the company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease.
WASHINGTON - A Senate committee on Wednesday unanimously approved a much-awaited overhaul of the nation's food safety laws, though it gave little hint of how it would pay for the sweeping but costly reform of the Food and Drug Administration's system for protecting much of what the nation eats and drinks. Lawmakers gave themselves some time to figu
Sun Pharmaceutical Industries, headquartered in India, has received the FDA's tentative approval for an abbreviated new drug application for generic Gleevec, imatinib mesylate tablets. The imatinib mesylate tablets, therapeutically equivalent to Gleevec tablets from Novartis, have two strengths, 100mg and 400mg.
Guided Therapy Systems, LLC, a leading medical technology company, is the first company in the world to develop and commercialize products that employ a unique form of ultrasound technology, Intense Therapeutic Ultrasound. Addressing a $4 billion market, the company's patented products combine ultrasound imaging with ultrasound treatment in a singl
Nov. 18Today's technology-laden operating rooms rely on the centuries-old practice of nurses visually counting instruments and surgical sponges what goes in should come out. Studies indicate, however, that one in every 1,000 to 1,500 abdominal surgeries results in a sponge being left behind. A five-year-old, Ross-based company has developed a
Endologix, Inc., developer of minimally invasive treatments for aortic disorders, announced today that it has received Investigational Device Exemption conditional approval from the United States Food and Drug Administration to begin a prospective, multicenter, randomized clinical trial for a bilateral percutaneous approach to endovascular abdomina
The U.S. Food and Drug Administration says it has approved a medicated skin patch that relieves the pain associated with shingles. The FDA said the Qutenza 8 percent patch treats pain that occurs after a shingles attack post-herpetic neuralgia. PHN is a condition affecting nerve fibers that can cause excruciating pain, the FDA said. Qutenza cont
Covidien, a leading global provider of healthcare products, and Nuvo Research Inc., a Canadian drug development company, announced that the U.S. Food and Drug Administration has approved the New Drug Application for Pennsaid Topical Solution 1.5% w/w. Pennsaid Topical Solution is a non-steroidal anti-inflammatory drug used for the treatment of th
18 November 2009 - Indian pharmaceutical and biotechnology company Wockhardt Ltd said today that the US FoodaA' and Drug Administration approved the company's 25 mg/10 ml injection of Nicardipine HCl for short-term management of hypertension or increased blood pressure. Nicardipine is the generic name for the brand Cardene, marketed in the USA by l
SQI Diagnostics Inc., a medical systems automation company focused on evolving laboratory-based biomarker testing, announced that the U.S. Food and Drug Administration has cleared the Company's automated SQiDworks Diagnostics Platform and its multiplexed IgXPLEX rheumatoid arthritis assay for marketing in the United States.
NeurogesX, a biopharmaceutical company, has received the FDA's approval for Qutenza 8% patch for the management of neuropathic pain due to postherpetic neuralgia, or PHN, the nerve pain which can follow shingles.
Par Pharmaceutical Companies has received the FDA's final approval for its abbreviated new drug application for the 100mg and 200mg strengths of tramadol ER. Par has been awarded 180 days of marketing exclusivity, commencing at launch, for being the first to file an abbreviated new drug application containing a paragraph IV certification for the pr
18 November 2009 - US medical device company SafeStitch Medical Inc said yesterday it has obtained 510 clearance from the US Food and Drug Administration to market its AMID Stapler with the intended use in general surgery procedures for fixation of mesh, in the repair of hernia defects and in other surgical specialties for the approximation of tiss
Minimally invasive surgery system easy for surgeons to implant and manipulate. Spineology Inc., developer and manufacturer of minimally invasive spinal surgery devices, announced today that it has received FDA clearance for its minimally invasive surgery Capture Facet Screw System.
On Monday, November 2, 2009, Andrea Natale, M.D., F.A.C.C., F.H.R.S., an electrophysiologist and executive medical director of the Texas Cardiac Arrhythmia Institute at St. David's Medical Center, will be the first physician in the United States to perform an ablation procedure to treat a patient with a cardiac arrhythmia, commonly known as an irre
Xanodyne Pharmaceuticals has reported that Lysteda oral tablets have received the FDA's approval for treatment of women suffering from cyclic heavy menstrual bleeding, also known as menorrhagia. Lysteda was approved following a priority review by the FDA and is a non-hormonal, oral therapeutic agent indicated specifically for this condition, said X
17 November 2009 - American Biotech Labs LLC said today that the US Food and Drug Administration has cleared for marketing its ASAP Antibacterial Silver Wound Dressing Gel as a prescription 510 medical device. The company said that the product utilises its patented nano-catalytic SilverSol Technology.
ASAP Antibacterial Silver Wound Dressing Gel is now cleared as a 510 medical device "for use in the management of 1st and 2nd degree burns, stasis...pressure... diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites"; new ASAP product "has been shown to inhibit the gro
