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Drugs in the News,
 FDA Approves ADCIRCA(TM) (Tadalafil) Tablets for the Treatment of Pulmonary Arterial Hypertension
United Therapeutics Corporation (NASDAQ:UTHR) announced today that the United States Food and Drug Administration (FDA) has approved ADCIRCA(TM) (tadalafil) tablets for oral administration, with a recommended dose of 40 mg, as the first once-daily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH). ADCIRCA is indicated to improve exercise ability in WHO Group I PAH patients, which encompasses patients with multiple forms of PAH including etiologies such as idiopathic and familial PAH as well as PAH associated with scleroderma and congenital heart disease.
HRA Pharma Granted European Marketing Authorization for ellaOne(R)
HRA Pharma (http://www.hra-pharma.com), a privately-held, European pharmaceutical company that designs products, devices and supporting services in reproductive health and endocrinology, announced today that ellaOne(R) (ulipristal acetate), its next generation emergency contraceptive, has been granted marketing authorization by the European Commission. The unanimous decision by all member states enables HRA Pharma to begin marketing ellaOne throughout the European Union, making it the only approved product to have been specifically designed and developed for use as an emergency contraceptive.
World-First Launch of New Heart Drug
UK patients are the first to benefit from the launch of a new heart drug prasugrel (Efient), following authorisation by the European Medicines Agency (EMEA). The availability of prasugrel offers fresh hope to patients who have unstable angina or have had a heart attack - known as Acute Coronary Syndromes (ACS)(1) - who undergo a PCI* procedure (angioplasty) to re-open a narrowed or blocked artery. When taken with aspirin, data shows that prasugrel may help prevent further cardiovascular events (such as a heart attacks and stroke) in these patients.
Cantel Medical Corp.'s Medivators Group Gains FDA 510(k) Approval For Its Advantage(TM) Plus Endoscope Reprocessing System
CANTEL MEDICAL CORP. (NYSE:CMN) announced today that the FDA has cleared its Medivators Advantage Plus Endoscope Reprocessing System and new Rapicide(R) PA High Level Disinfectant for sale in the United States. The Advantage Plus System, with its accompanying new chemistry, represents the latest in a long line of "state of the art", innovative reprocessing technologies that Medivators has been delivering to hospitals and stand-alone GI centers for over 20 years.
FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD)
AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has approved SYMBICORT (budesonide/formoterol fumarate dihydrate) 160/4.5 mcg for the twice daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.(2) The FDA approval is based on results from two pivotal clinical trials, SHINE (6-month) and SUN (12-month),(2) which found SYMBICORT significantly improved lung function within five minutes of the first dose(1) and sustained that lung function improvement for the duration of the studies.(3) SYMBICORT pMDI (pressurized metered-dose inhaler) has been available in the U.S. since June 2007 for the long-term maintenance treatment of asthma in patients 12 years of age and older.
Stereotaxis Announces FDA Approval of the NAVISTAR(R) RMT THERMOCOOL(R) Catheter
Stereotaxis, Inc. (NASDAQ: STXS) announced today that the U.S. Food and Drug Administration approved for marketing the NAVISTAR(R) RMT THERMOCOOL(R) Catheter, which is manufactured by Biosense Webster, Inc, a Johnson & Johnson company. The NAVISTAR(R) RMT THERMOCOOL(R) Catheter is used with Stereotaxis' NIOBE(R) Remote Magnetic Navigation System for mapping and radiofrequency (RF) ablation to treat irregular heartbeats, or cardiac arrhythmias. Stereotaxis expects that shipments of the catheter to customers will begin within the next few weeks.
Derma Sciences Gains FDA Clearance for Novel BIOGUARD(TM) Barrier Dressing with NIMBUS(R) Technology
Derma Sciences, Inc. (BULLETIN BOARD: DSCI) , a provider of advanced wound care products, announced today that its first BIOGUARD Barrier Dressings have received clearance from the U.S. Food and Drug Administration for marketing and distribution. BIOGUARD will offer surgeons, wound care clinicians, infection control experts and primary care doctors a new weapon against the transmission of such virulent bacteria as Methicillin-resistant Staphylococcus aureus (MRSA). Coming on the heels of Derma Sciences' successful launch of its MEDIHONEY(TM) dressing line in 2008, BIOGUARD is the company's latest new product entrant into the $14 billion global wound care market. Sales of the dressings are expected to commence in June, 2009.
Varian Medical Systems Has Received CE Mark for Proton Therapy System
Varian Medical Systems (NYSE:VAR) today announced that it has received CE mark for the Varian Proton Therapy System, which is designed to help doctors to improve treatments and outcomes in many cancer cases. With proton therapy, doctors can use higher doses of radiation to control and manage tumors while significantly reducing damage to healthy tissue and vital organs.
European Commisssion Grants Ferring Pharmaceuticals Approval of FIRMAGON(R)
deCODE Receives California Clinical Laboratory License
deCODE genetics (Nasdaq:DCGN) today announced that it has received a clinical laboratory license from the State of California. The quality and scale of deCODE's in-house, CLIA-registered genotyping laboratory underpins deCODE's global leadership in the discovery of variations in the sequence of the human genome conferring risk of common diseases. The same staff and facility also process deCODE's DNA-based reference laboratory tests for gauging individual risk of major public health challenges ranging from heart attack to breast cancer, as well as the company's pioneering deCODEme(TM) scans, the world's first personal genome analysis and focused disease area scans. With this license, California residents can now benefit from the unrivalled quality of deCODE products for understanding risk and, working with their physicians, empowering the prevention of common diseases.
(Degarelix) for Treatment of Prostate Cancer
Ferring Pharmaceuticals announced today that it has received marketing authorisation from the European Commission, for FIRMAGON(R) (degarelix), a new GnRH receptor antagonist indicated for patients with advanced, hormone-dependent prostate cancer.
In Phase III studies degarelix produced a significant reduction in levels of testosterone (i,ii) within three days in more than 96% of study patients.(ii) Testosterone plays a major role in the growth and spread of prostate cancer cells.
European Medicines Agency Recommends Suspension of Marketing Authorization for Raptiva(R)
Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the European Medicines Agency (EMEA) has recommended to the European Commission the suspension of the marketing authorization for Raptiva(R) (efalizumab). Raptiva(R) is currently approved for the treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to certain other systemic therapies.
ROXRO Announces FDA Accepts for Review NDA for ROX-888 for the Management of Acute Moderate to Severe Pain
ROXRO announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its lead investigational prescription drug candidate, ROX-888, for the management of acute moderate to severe pain. ROX-888 is an intranasal formulation of ketorolac, a non-steroidal anti-inflammatory drug (NSAID), designed to provide ambulatory patients with a convenient, potent, and fast-acting option for acute pain relief, without the risk of addiction or the other negative effects of narcotics. The NDA package for ROX-888 includes data from more than 1,000 subjects and 14 clinical trials. If approved, ROX-888 is expected to be the first non-narcotic intranasal analgesic indicated for the management of acute moderate to severe pain.
Galderma Wins FDA Approval for Vectical(TM) Ointment, a Novel Topical Therapy for Mild-to-Moderate Plaque Psoriasis
Galderma Laboratories, L.P. today announced that the U.S. Food and Drug Administration (FDA) has approved Vectical(TM) (calcitriol) Ointment 3mcg/g, a unique vitamin D3 product for the treatment of mild-to-moderate plaque psoriasis in adults.
Zydus Cadila gets US FDA nod for three anti-epileptic drugsZydus Cadila has received three product approvals from the US FDA in quick succession. The group has received approvals to market lamotrigine chewable tablets in strengths of 2 mg, 5 mg and 25 mg.
Mylan Receives FDA Approval for First-to-File Generic Depakote(R) ER
Mylan Inc. (NASDAQ:MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Divalproex Sodium Extended-release (Divalproex ER) Tablets, 250 mg and 500 mg.
AdvanDx Receives FDA 510(k) Clearance for E. coli/P. aeruginosa PNA FISH(R)
AdvanDx today announced it received FDA 510(k) clearance for E. coli/P. aeruginosa PNA FISH(R) to identify Escherichia coli and/or Pseudomonas aeruginosa directly from positive blood cultures. E. coli/P. aeruginosa PNA FISH is the first-ever test for identifying E. coli and P. aeruginosa directly from positive blood cultures and the latest addition to AdvanDx's easy-to-use, molecular-based PNA FISH diagnostics platform. PNA FISH tests now provide rapid species identification for the vast majority of Gram-stain results in hours instead of days, enabling therapy guiding results for 95-99% of patients with positive blood cultures.
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