FDA Greenlights Pneumonia Vaccine
The FDA has approved Prevnar 13, for use on people over 50. Prevnar 13 is a pneumococcal 13-valent conjugate vaccine, that can prevent pneumonia and disease caused by the bacterium, Streptococcus pneumoniae. The bacterium most commonly infects the lungs, (Pneumococcal pneumonia), causing congestion and a potentially fatal build up of fluid and mucus. However it can become more invasive entering the spinal fluid, and even the blood. Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research said: "According to recent information for the United States, it is estimated that approximately 300,000 adults 50 years of age and older are hospitalized yearly because of pneumococcal pneumonia ... Pneumococcal disease is a substantial cause of illness and death. Today's approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group." Prevnar or Prevnar 13 is made by Pfizer while GlaxoSmithKline market a similar product under the name of Synflorix. They were approved in Feb. 2010 for use in children ages 6 weeks through 5 years for the prevention of invasive disease caused by 13 different serotypes of the bacterium Streptococcus pneumoniae and for the prevention of otitis media caused by seven of the serotypes of the bacterium. In the more recent randomized, multi-center studies in the United States and Europe, people 50 and older received either Prevnar 13 or Pneumovax 23, a licensed pneumococcal vaccine also approved for use in this age group. The trials showed Prevnar 13 inducing antibody levels that were either comparable to or higher than the levels induced by Pneumovax 23. Therefore the FDA used their new accelerated approval pathway, that allows for earlier treatment for serious and life threatening illnesses. The pathway allows for the demonstration of effectiveness of a vaccine using an immune marker that is reasonably likely to predict clinical benefit. To assure the safety of the product, 6000 people aged 50 who had not received the Prenumovax23 were given Prevnar 13 as an alternative. Common adverse reactions reported with Prevnar 13 were pain, redness, and swelling at the injection site, limitation of movement of the injected arm, fatigue, headache, chills, decreased appetite, generalized muscle pain, and joint pain. Similar reactions were observed in those who received Pneumovax 23. The accelerated approval means that the product can be more widely used whilst full clinical trials are being conducted. In addition, another research is being conducted on 85,000 patients 65 and over, who have not previously received Pneumovax 23, to assess the effectiveness and clinical benefit of Prevnar 13 in preventing pneumococcal pneumonia.

FDA Okays BP Drug Combo
The FDA has approved the combination of azilsartan medoxomil and chlorthalidone (Edarbyclor) for hypertension treatment in adult patients. The tablet is the first single-tablet, once-daily, fixed-dose treatment to combine an angiotensin II receptor blocker (azilsartan medoxomil, Edarbi) and a diuretic (chlorthalidone), according to a statement from maker Takeda Pharmaceuticals. Drug safety and efficacy were shown in five phase III trials that included over 5,000 hypertensive patients. Trials lasted from eight to 52 weeks and included drug doses of 20/12.5 mg to 80/25 mg. Data from the trials showed the combination lowered mean trough systolic blood pressure significantly versus azilsartan medoxomil or chlorthalidone alone. It also lowered blood pressure in black and non-black patients similarly. Finally, the combination lowered clinic systolic blood pressure significantly more than 40/25 mg doses of medoxomil/hydrochlorothiazide at the same dosage. The recommended starting dose is 40/12.5 mg daily and the maximum is 40/25 mg daily, the release said. Edarbyclor was approved with a boxed warning for fetal toxicity and is contraindicated in patients with anuria. Patients with activated renin-angiotensin-aldosterone systems may experience excessive hypotension and should have volume and salt depletion corrected prior to treatment. The drug combination may worsen renal function in patients with renal impairment, may cause renal failure in patients with renal artery stenosis, and may precipitate azotemia in patients with renal disease. Adverse effects include hypokalemia, attenuated hypokalemia, dizziness, fatigue, and transient creatine elevation.

Boca Pharmacal Receives FDA Approval On Hydrocodone Bitartrate And Acetaminophen Oral Solution

Boca Pharmacal, Inc., announced that it has received approval from the FDA of its Abbreviated New Drug Application (ANDA) for Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5mg / 325mg per 5mL, the generic version of Hycet® Oral Solution distributed by FSC Laboratories, Inc. Hydrocodone Bitartrate and Acetaminophen Oral Solution is used for treatment for the relief of moderate to moderately severe pain.

FDA Approves Arcapta Neohaler To Treat Chronic Obstructive Pulmonary Disease

The U.S. Food and Drug Administration approved Arcapta Neohaler (indacaterol inhalation powder) for the long term, once-daily maintenance bronchodilator treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. Arcapta Neohaler is a new molecular entity in the beta2-adrenergic agonist class that helps muscles around the airways of the lungs stay relaxed to prevent symptoms of COPD, such as wheezing and breathlessness. Arcapta Neohaler is not intended to treat asthma or sudden, severe symptoms of COPD. Arcapta Neohaler carries a boxed warning that long-acting beta2 adrenergic agonists (LABA) increase the risk of asthma-related death. All LABA, including Arcapta Neohaler, should not be used in patients with asthma, unless used with a long-term asthma control medication. The most common side effects reported by those using Arcapta Neohaler include runny nose, cough, sore throat, headache and nausea.

FDA Approves Generic Levofloxacin

The FDA has approved the first generic versions of the antibiotic levofloxacin (Levaquin) for patients 18 and older. The drug is indicated to treat mild, moderate, or severe bacterial infections of the skin, sinus, kidney, bladder, and prostate caused by certain germs. It is also used to treat people exposed to inhalational anthrax and some bacterial infections that cause bronchitis and pneumonia. Like all fluoroquinolones, levofloxacin comes with a boxed warning for an increased risk of tendinitis and tendon rupture, a statement from the FDA said. The risk is elevated in patients older than 60; those taking corticosteroids; and kidney, heart, and lung transplant patients. The warning also notes the drug may worsen muscle weakness in myasthenia gravis, a chronic autoimmune neuromuscular disease. Approval for the generic went to 12 companies, including:

• AkornAurobindo
• Pharma
• Dr. Reddy's Laboratories
• Glenmark Generics
• Hi-Tech Pharmacal
• Lupin
• Mylan Pharmaceuticals
• Sagent Strides
• Sandoz
• Teva Pharmaceuticals
• Torrent Pharmaceuticals
• Wockhardt

Generic forms approved include tablet, oral solution, and injectable solution.

FDA Okays New Abuse-Resistant Opioid

The FDA has approved a short-acting opioid painkiller with abuse-deterrent properties, the drugmaker Pfizer announced Monday. Oxecta, a new formulation of oxycodone, had previously been under development as Acurox, which included niacin to deter oral abuse. That version received a thumbs down from an FDA advisory panel in 2009. The new drug uses "Aversion" technology, licensed from Acura Pharmaceuticals - which is described as a "unique composition of commonly used pharmaceutical ingredients" - to stop potential abusers from crushing, chewing, snorting, or injecting the opioid. It does not deter oral abuse. But Pfizer noted in a statement that the potential to abuse the drug via these routes still exists and "there is no evidence that Oxecta has a reduced abuse liability compared to immediate-release oxycodone." The technology causes the drug to break down into crumbled chunks instead of powder if crushed, and turns it "sudsy" if it is mixed with liquid and drawn into a syringe. Oxecta is indicated for acute and chronic moderate-to-severe pain and is contraindicated in patients with respiratory depression, paralytic ileus, bronchial asthma or hypercarbia, and in those with a hypersensitivity to the opioid. Among the most common adverse reactions are nausea, constipation, vomiting, headache, itchiness, trouble sleeping, and dizziness, according to Pfizer. The new formulation joins a handful of other abuse-deterrent opioids that are on the market or in development. Purdue Pharmaceuticals, maker of long-acting oxycodone (OxyContin), had a tamper-proof version of its drug approved last year. Making drugs harder to abuse has been one key strategy for some companies in an attempt to control what the government has deemed an epidemic of prescription painkiller abuse.

FDA Approves Two Hydrocodone Cough and Cold Medications

The FDA approved ZUTRIPRO™ (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine HCl) Oral Solution (CIII) and REZIRA™ (hydrocodone bitartrate and pseudoephedrine HCl) Oral Solution (CIII). Both products are indicated for the relief of cough and symptoms associated with the common cold. ZUTRIPRO™ and REZIRA™ Oral Solutions are the only FDA approved hydrocodone cough and cold combinations containing a nasal decongestant1. The approval of ZUTRIPRO™ and REZIRA™ Oral Solutions marks the first NDA approval by the FDA for a liquid hydrocodone cough medication since 19901.

FDA Okays PET/MRI Scanner

The FDA has cleared the first device that simultaneously performs PET and MRI scans. Using a single system, the Siemens Biograph mMR shows the function of organs, soft tissues, and other internal bodily structures (PET), while providing simultaneous images (MRI) of those organs. The PET/MRI scanner offers reduced total radiation dose and increased soft-tissue contrast, the FDA said in a statement. Although the PET component will still require the injection of a radioactive contrast agent to obtain the scan, there is no ionizing radiation used during the MRI scan. PET/MRI allows for imaging at a significantly lower radiation dose compared to PET/CT. Lower radiation is important for children and adult patients undergoing multiple scans.

Amneal Receives FDA Approval For Nitrofurantoin Oral Suspension
Amneal Pharmaceuticals has received FDA approval to manufacture Nitrofurantoin Oral Suspension in the 25 mg/5 ml strength effective May 13, 2011. Amneal's generic, the first on the market, is an AA-rated, therapeutically equivalent alternative to Furadantin® (a registered trademark of Shionogi Pharma, Inc.). Nitrofurantoin Oral Suspension is an anti-bacterial medication indicated for the treatment of urinary tract infection (UTI). Amneal will sell its generic in 8 oz/230 ml size bottles. The clear yellow, tutti fruitti-flavored liquid does not require refrigeration.

Taro Receives FDA Approval For Cetirizine Hydrochloride Oral Solution, 1 Mg/mL (Sugar Free Bubble Gum Flavor)
Taro Pharmaceutical has received approval from the FDA for its Abbreviated New Drug Application for Cetirizine Hydrochloride Oral Solution, 1 mg/mL (Sugar Free Bubble Gum) ("Cetirizine Oral Solution"). Taro's Cetirizine Oral Solution is an over-the-counter antihistamine used for the relief of sneezing, runny nose, itchy, watery eyes and itchy throat or nose due to indoor and outdoor allergies and for the relief of itching due to hives and is bioequivalent to Children's Zyrtec® Syrup, 5mg/5mL of McNeil Consumer Healthcare.

Taro Receives FDA Approval For Imiquimod Cream, 5%
Taro Pharmaceutical has received approval from the FDA for its Abbreviated New Drug Application (ANDA) for Imiquimod Cream, 5% ("imiquimod cream"). Taro's imiquimod cream is a prescription pharmaceutical product used for topical treatment of actinic keratosis and external genital warts and is bioequivalent to Aldara Cream, 5% of Graceway Pharmaceuticals.

FDA Approves Zyclara(R) (Imiquimod) Cream, 3.75% For The Treatment Of External Genital Warts
The FDA has approved Zyclara® Cream for the treatment of external genital and perianal warts (EGW) in patients 12 years of age and older. Zyclara Cream's clinical studies demonstrated that using its once-daily treatment regimen, for up to eight weeks, safely and effectively clears genital warts. In addition, data showed that of those patients who achieved complete clearance, only a small number experienced a recurrence of their wart(s) 12 weeks after treatment. Most approved topical prescription treatments currently available to treat EGW are associated with lengthy treatment regimens, which may impact patient compliance. Zyclara Cream was developed to meet the need for a shorter treatment regimen, while maintaining the efficacy (both initial and sustained clearance) that imiquimod has delivered for more than a decade.

FDA Okays Dermatitis Gel
The FDA has approved a new skin care gel for treatment of various dermatoses, burns, and dry and waxy skin. Epicyn HydroGel -- approved as a medical device -- is indicated to treat burning, itching, and pain associated with atopic dermatitis and radiation dermatitis, as well as pain from first- and second-degree burns. The gel also maintains "a moist wound and skin environment" to help treat dry and waxy skin. The device, which is available by prescription only, is based on Oculus Innovative Sciences' existing Microcyn oxychlorine compound and is a shelf-stable hypochlorous acid formulation.

FDA Okays New Hypertension Polypill
The FDA has approved a combination of three hypertension drugs - olmesartan medoxomil, amlodipine, and hydrochlorothiazide (Tribenzor) - to treat patients whose blood pressure is not controlled on angiotensin receptor blockers, calcium channel blockers, or diuretics. The new polypill is not approved as an initial therapy for hypertension. The polypill reduced patient systolic/diastolic blood pressures compared with amlodipine/hydrochlorothiazide, olmesartan/hydrochlorothiazide, and olmesartan/amlodipine by an average of 8.1/5.4 mm Hg, 7.6/5.4 mm Hg, and 8.4/4.5 mm Hg respectively (P<0.0001 versus each dual combination) from the 168.5/100.9 mm Hg average baseline. The FDA warned that pregnant patients should not take the new combination drug; those who become pregnant while on the polypill should discontinue therapy immediately.

HeadCoolie^TM Adjustable, Reusable Head Wrap Provides Non-Chemical, Non-Prescription Therapeutic Relief For Fever Symptoms And Headaches
The FDA has cleared Roche's new LightCycler® MRSA Advanced Test for the detection of methicillin-resistant Staphylococcus aureus (MRSA) for clinical use in the United States. The LightCycler® MRSA Advanced Test is a qualitative in-vitro diagnostic test for the direct detection of nasal colonization with bacterial MRSA, and it is designed to aid in the prevention and control of MRSA infections in healthcare settings. The polymerase chain reaction (PCR) test delivers rapid results (within two hours) and appears to have better sensitivity compared to direct culture-based methods.

Merck Receives Marketing Approval For Dulera
Merck & Co. has received marketing approval for its asthma treatment Dulera [mometasone furoate and formoterol fumarate dehydrate]. The FDA cleared the treatment which comes in an inhaler, for use in patients 12 and older who have "poorly controlled asthma. Others are urged to refrain from Dulera which combines two types of medication because of the slight risk that one component could cause asthma-related death. The product, which is not approved for relief of acute bronchospasm, will be offered in two strengths.

FDA Okays Combo Pill to Treat Arthritis Pain and Protect Against Gastric Ulcers
The FDA has approved a new pill that combines a non-steroidal anti-inflammatory with a proton pump inhibitor in a delayed release formulation for treatment of arthritis pain and pain associated with ankylosing spondylitis -- a combination specifically designed to reduce the risk of NSAID-associated gastric ulcers. The combo pill, which will be marketed as Vimovo, contains a fixed-dose combination of delayed-release enteric-coated naproxen and immediate release esomeprazole. 

FDA Approves First-of-a-Kind Asthma Device
The FDA has approved a new device for the treatment of severe and persistent asthma, which uses radiofrequency energy to smooth and prevent airway constriction in lieu of corticosteroids. The Alair Bronchial Thermoplasty System consists of a catheter with an electrode tip and a controller unit that generates the asthma-handling electromagnetic energy. The device is installed through the nose or mouth and into the lungs, where it uses heat from the electric energy to reduce the thickness of smooth muscle that narrows the airways in patients with asthma.

SUMAVEL DosePro Available In the US To Treat Acute Migraine And Cluster Headaches
Zogenix and Astellas Pharma U.S. have announced the launch of SUMAVEL™ DosePro™ (sumatriptan injection) needle-free delivery system for acute migraines and cluster headaches. In July 2009, the U.S. Food and Drug Administration approved SUMAVEL DosePro for the acute treatment of migraine, with or without aura, and the acute treatment of cluster headaches. SUMAVEL DosePro delivers subcutaneous sumatriptan, a treatment that provides migraine relief starting within 10 minutes for some patients, in a first-of-its-kind needle-free delivery system. SUMAVEL DosePro is expected to be available at most retail pharmacy outlets this month.

Cool technology for 2010

FiatLux Visualize Free: FiatLux Imaging has announced that it is making available for download its FiatLux Visualize Free application. The software is a 2D/3D DICOM viewer for CT & MRI data. Go to http://www.fiatluximaging.com/index2.htm to download.

Drug Seeker: This HIPAA-compliant, password-protected application helps docs keep track of patients who may be seeking narcotics from other physicians. Available from the iTunes App Store.

FDA Okays Low-Dose Local Estrogen
The FDA has approved a low-dose local estrogen therapy, a 10 mcg formulation of the estradiol vaginal tablet Vagifem, for atrophic vaginitis. The therapy was first approved in a 25 mcg dose in 1999. In studies, the most common side effects among patients using the estradiol tablets were vulvovaginal mycotic infection, back pain, and vulvovaginal pruritus. Side effects associated with estrogen treatment in general include increased risk of uteral cancer, including vaginal bleeding associated with cancer, stroke, blood clot, headache, breast pain, irregular vaginal bleeding or spotting, stomach and abdominal cramps, bloating, nausea, hair loss, fluid retention, and yeast infection. Patients taking estrogens with progestins may face an increased risk of myocardial infarction and breast cancer. Patients 65 and older may be at increased risk of developing dementia while on estrogens with or without progestins.

Stryker Expands Offerings With "Low-Risk" OtisMed and Sonopet
Stryker has bolstered its portfolio of orthopaedic products by purchasing orthopaedic software firm OtisMed. OtisMed specializes in surgical software for knee replacement procedures and, according to Stryker, will specifically benefit its Triathlon knee system. OtisMed will be incorporated into Stryker’s orthopaedics division. Stryker has also bought assets related to the production of the Sonopet ultrasonic aspirator control consoles, hand pieces and accessories, from Japanese imaging and information company Mutoh and microsurgery expert Synergetics USA. The Sonopet system is a bone-cutting device for both soft and hard tissue.


FDA Approves HPV Vaccine for Men and Boys
The FDA approved Merck's Gardasil vaccine against human papillomavirus (HPV) for boys and men, the same day that it okayed .. Gardasil was approved for males ages 9 to 26 for prevention of genital warts. The approval did not address claims that the vaccine in this population may help prevent transmission to girls and women. The agency also approved the first competitor for Gardasil since the latter came on the market in 2006. GlaxoSmithKline's Cervarix was cleared for use in girls and women, 9 to 26 years old. Gardasil is given as three injections over a six-month period. Headache, fever, pain at the injection site, itching, redness, swelling, and bruising were the most common side effects observed in the clinical studies.

Theravance And Astellas Announce FDA Approval Of VIBATIVTM (telavancin) For The Treatment Of Complicated Skin And Skin Structure Infections
Theravance and Astellas Pharma US announced that the FDA has approved VIBATIV™ (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains. VIBATIV is a bactericidal, once-daily injectable lipoglycopeptide antibiotic discovered by Theravance. VIBATIV has demonstrated its efficacy and safety in clinical trials for the treatment of Gram-positive complicated skin and skin structure infections which included the largest cohort of patients with methicillin-resistant Staphylococcus aureus studied to date.

FDA Okays Vaccine for Hib Booster
The FDA has approved a new Haemophilus influenzae type b (Hib) vaccine – Hiberix  – for use as a booster dose from ages 15 months through four  years. The vaccine, made by GlaxoSmithKline, will be used to complete the four-dose series recommended by the CDC following immunizations at two, four, and six months. It was approved using an accelerated process that operates under the condition that clinical trials will continue during the postapproval marketing to confirm a benefit, the FDA said. The decision that Hiberix is safe and effective as a booster dose was based on data from seven clinical trials conducted in Europe, Latin America, and Canada in more than 1,000 children. The vaccine will help ease the effects of a nationwide shortage of Hib vaccine following the 2007 recall of certain lots of two of the four vaccines licensed at that time  – Merck's and COMVAX. The CDC originally recommended deferring the booster dose until the vaccine supply could be restored. But it rescinded that guidance in June on the recommendation of its Advisory Committee on Immunization Practices. The panel noted that two new vaccines  – ActHIB and Pentacel by Sanofi Pasteur  –  were now available. Although the CDC now recommends children get the full course of immunizations, there is still not enough vaccine to recall all children who deferred the booster dose in a mass effort. The agency said these children can receive the booster dose during routine office visits. The most common side effects seen with the Hiberix booster are pain, redness at the injection site, fever, fussiness, loss of appetite and restlessness, according to the FDA.

FDA Approves New Cholesterol-Lowering Drug
The FDA 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. Like other statins, Livalo is intended for patients when diet and exercise fail to lower their cholesterol levels. Livalo was approved on the basis of five clinical trials comparing its efficacy and safety to that of three currently marketed statins. The most frequently reported adverse reactions from taking Livalo were muscle pain, back pain, joint pain and constipation.

FDA Approves Painkiller Designed to be Abuse-Resistant
King Pharmaceuticals won US approval to sell the first pain pill that users may not easily manipulate to get high. The drug, Embeda, contains a chemical designed to counteract the morphine if the capsule is crushed, chewed or dissolved in alcohol to get the full dose at once.  King Pharmaceuticals said, and the FDA agreed, the evidence wasn't conclusive that the chemical truly interfered with the morphine high.The prescribing information and medication guide will include data about two studies that show no evidence the naltrexone reduces euphoria when Embeda is crushed or chewed.  King Pharmaceuticals said it will launch Embeda in September.

Mylan Receives FDA Approval for Generic Version Of Migraine Treatment Imitrex(R)
Mylan Pharmaceuticals has received approval from the FDA for its Abbreviated New Drug Application (ANDA) for Sumatriptan Succinate Tablets, 25 mg (base), 50 mg (base) and 100 mg (base). Mylan's Sumatriptan Succinate Tablets are the generic version of GlaxoSmithKline's migraine treatment Imitrex(R).

Watson Pharmaceuticals Receives FDA Approval for Generic Toprol XL(R) 25 MG and 50 MG
Watson Pharmaceuticals has received approval from the FDA on its Abbreviated New Drug Applications (ANDAs) for metoprolol succinate extended-release tablets USP in the 25 mg and 50 mg strengths. Metoprolol succinate extended-release tablets are the generic equivalent to AstraZeneca's Toprol XL(R) tablets. Metoprolol succinate extended-release is a beta-blocker used to treat angina, heart failure and high blood pressure. Watson intends to launch the product immediately.

FDA Approves New Cholesterol-Lowering Drug
The FDA has approved a seventh statin drug -- pitavastatin (Livalo). The new statin is indicated for primary hypercholesterolemia and combined dyslipidemia to improve blood cholesterol levels when diet and exercise fail. Pitavastatin joins simvastatin (Zocor), atorvastatin (Lipitor), pravastatin (Pravachol), rosuvastatin (Crestor), fluvastatin (Lescol), and lovastatin (Mevacor). Manufactured by Kowa Pharmaceuticals  pitavastatin's structure contains a cyclopropyl group not seen other statins that contributes to a more effective inhibition of cholesterol production and may result in greater LDL cholesterol clearance and reduced plasma cholesterol. FDA approval was based on five clinical trials comparing the drug's efficacy and safety to simvastatin, atorvastatin, and pravastatin. The drug will be available in 1, 2, and 4 mg dosages.

FDA Approves Cetirizine Hydrochloride Tablets (OTC) ANDA for Hay Fever and Other Respiratory Allergies
Taro Pharmaceutical Industries has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for cetirizine hydrochloride tablets (OTC), 5 mg and 10 mg (Cetirizine Tablets). Cetirizine Tablets are a nonprescription drug approved for the temporary relief of symptoms due to hay fever or other respiratory allergies (sneezing; runny nose; itchy, watery eyes; itchy throat or nose) in adults and children 2 years of age and older. Cetirizine Tablets are also approved for the relief of itching due to hives in adults and children 6 years of age and older. Taro's Cetirizine Tablets are bioequivalent to McNeil Consumer Healthcare's Zyrtec® Allergy Tablets, 5 mg and 10 mg and Zyrtec® Hives Relief Tablets, 5 mg and 10 mg. Taro previously received approval for cetirizine hydrochloride oral solution in April 2008.

New Silver Nanoparticle Skin Gel For Healing Burns
Scientists in India are reporting successful laboratory tests of a new and potentially safer alternative to silver-based gels applied to the skin of burn patients to treat infections. With names like silver sulfadiazine and silver nitrate, these germ-fighters save lives and speed healing. The researchers describe gel composed of silver nanoparticles - each 1/50,000th the width of a human hair - that appears more effective than these traditional gels. The scientists note that antimicrobial silver compounds have been used for decades on burn patients, whose damaged skin is highly vulnerable to bacterial infections. However, topical silver agents now in use can loose effectiveness in the body, cause skin discoloration, and damage cells. Drug-resistant bacteria can make these treatments less effective.

Zogenix Obtains Approval In U.S. For Sumavel™ DosePro™
Aradigm Corporation announced that Zogenix, Inc. was granted approval of the Sumavel™ DosePro™ (sumatriptan injection) needle-free delivery system which enables subcutaneous delivery of sumatriptan without a needle for the treatment of acute migraine. Sumavel DosePro uses the novel, proprietary DosePro drug delivery system to subcutaneously administer sumatriptan, a medication that has been used to treat migraines effectively and safely for over fifteen years, but without many of the issues associated with needle delivery. Sumavel DosePro has the potential of offering migraine relief beginning in as little as ten minutes, in a system sufferers can self administer in three easy steps. Given the unique attributes of Sumavel DosePro, Zogenix believes it has the potential to be used as a replacement for needle-based injectable forms of sumatriptan, as well as to replace tablet and nasal spray triptans for challenging migraine episodes. Migraine affects approximately 30 million people in the United States.