FDA Approves First Generic Ropinirole
FDA has approved the first generic versions of Requip tablets for the treatment of moderate to severe Restless Legs Syndrome.
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Medicare To Protect Beneficiaries In Advantage, Prescription Programs
Medicare proposes new way to protect Medicare beneficiaries in Medicare Advantage and Prescription Drug Programs and tightens marketing standards protecting beneficiaries from inappropriate cost sharing.
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Barr Announces Approval Of Generic Yasmin
Barr Laboratories has received final approval from FDA for ANDA to manufacture and market a generic version of Yasmin, an oral contraceptive product manufactured and marketed by Bayer Schering Pharma, AG.
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Roxane Launches Ropinirole Hydrochloride Tablets
Roxane Laboratories announced the approval of its ANDA for Ropinirole Hydrochloride Tablets, 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, 5mg by FDA.
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Some Drug Prices Can Vary By $100 Or More
For consumers who pay for all or most of their prescription drugs out of pocket, a new price study by Consumer Reports finds that it pays to shop around.
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Novartis' Meningitis Vaccine Shows Treatment Promise
Novartis' clinical trial of meningitis vaccine Menveo showed the drug successfully boosts immune system possibly becoming a treatment in the future.
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FDA Approves Advair For COPD
FDA approved Advair Diskus for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) who have a history of exacerbations.
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Does Your Doctor Still Use Paper Prescriptions?
In 2007, patients in US left their doctors office with at least one prescription on 550 million separate occasions.
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Merck Receives Not Approvable Letter From FDA for MK-0524A
Two days ago Merck received a Not Approvable action letter from the U.S. Food and Drug Administration (FDA) for the Company's New Drug Application (NDA) for MK-0524A (ER niacin/laropiprant) for the treatment of primary hypercholesterolemia or mixed dyslipidemia.
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FDA To Fill 1300 New Positions To Improve Drug Safety
The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation.
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FDA Approves Amitiza For IBS-C
FDA approved Amitiza for the treatment of Irritable Bowel Syndrome with Constipation in adult women aged 18 and over.
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Lupin Launches Suprax 400mg Tablets
Lupin Pharmaceuticals launches Suprax 400mg Tablets (Cefixime USP) in the US.
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FDA: Give Authority To Improve Prescription Drug Safety
In order to improve the safety of imported prescription drugs and medications FDA asks the Congress for more authority and resources.
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Extra Ingredients Prompt Digitek Digoxin Recall
The fact that the heart failure treatment drug Digitek (Digoxin) may contain twice the approved level of active ingredient than is appropriate has prompted Digitek recall by Actavis Totowa.
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Actavis Totowa Recalls Bertek And UDL Laboratories Digitek
Actavis Totowa is initiating a Class I nationwide recall of Digitek (digoxin tablets, USP, all strengths) for oral use.
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FDA Approves Breckenridge's Generic Activella
FDA has granted final approval for Breckenridge Pharmaceutical's ANDA to market its generic version of Novo Nordisk's Activella Tablets (Estradiol/Norethindrone Acetate 1.0mg / 0.5mg) Tablets.
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Heritage Introduces Nimodipine Soft Gel Capsules
Heritage Pharmaceuticals announced the immediate availability of Nimodipine Soft Gelatin Capsules in 30 mg strength.
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Editor Addresses High-Cost Specialty Drugs
USA Today published an opposing viewpoint editorial and opinion piece addressing so-called "tiered" pricing for prescription drugs.
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Vioxx-Ghostwriters Write Medical Studies
Litigation involving drug maker Merck has revealed new information about safety concerns associated with the drug Vioxx, pulled from the market in 2004. Legal documents recently made public show the company found an increased risk in mortality rates during clinical trials to treat patients with Alzheimer's disease but the dangers were never made clear to the public.
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FDA Approves Lexiscan Injection
FDA has approved Lexiscan injection, an A2A adenosine receptor agonist, for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging.
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One-Third Of Consumers Experience Prescription Errors
One-third of America's 225 million prescription-takers now report experiencing a prescription error or knowing someone who has.
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FDA Clears IgG Anti-AtherOx Test Kit
Corgenix Medical Corporation announced receipt of 510 clearance by FDA for the Company's IgG Anti-AtherOx Test Kit.
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Enanta Reports New Macrolide-Related Drug Class, Bicyclolides
Enanta Pharmaceuticals presents breakthrough research program to evaluate a new macrolide-related drug class, Bicyclolides, in the treatment of methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus, and other gram-positive infection pathogens.
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Nektar Terminates All Negotiations With Potential Partners For Inhaled Insulin
Nektar Therapeutics has ceased all negotiations with potential partners for its inhaled insulin programs as a result of new data analysis from ongoing clinical trials conducted by Pfizer Inc.
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Aida Pharmaceuticals Develops New Antibiotic Drug
Aida Pharmaceuticals is developing a new wide-spectrum antibiotic, Wetimicin.
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Prescription Drug Abuse Threatens Availability Of Pain Medication
Take a look in your medicine cabinet -- do you spot prescription pain medication?
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Pennsylvania Health Plans To Combat Cost Of Specialty Drugs
HealthLeaders-InterStudy reports that the high cost of specialty drugs is forcing Pennsylvania insurers to get creative in finding ways to control those costs.
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Paying More For Prescriptions May Limit Seniors' Access To Antidepressants
New cost-sharing policies may prevent some older adults diagnosed with depression from filling new antidepressant prescriptions.
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States May Recycle Prescription Drugs To Reduce Costs For Uninsured
At least 33 US states have implemented laws to allow or study programs that redistribute unused prescription medications to uninsured or low-income individuals.
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FDA Clears Thermo Fisher For MRSA Test Medium
Thermo Fisher Scientific has received FDA clearance for Spectra MRSA, a test designed to screen for methicillin-resistant Staphylococcus aureus.
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FORSTEO Receives Approval For Glucocorticoid-Induced Osteoporosis Treatment
European Commission has approved Eli Lilly and Company's new indication for FORSTEO for the treatment of osteoporosis associated with sustained, systemic glucocorticoid therapy in women and men at increased risk for fracture.
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FDA Approves New Vaccine To Prevent Gastroenteritis
FDA approved Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis in infants and children.
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China's Gastric Cancer Drug Market To Nearly Triple By 2012
Decision Resources forecasts that the Chinese gastric cancer drug market will nearly triple between 2007 and 2012.
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TV Drug Ads Should Include Information On Side Effects
One in six Americans who have ever taken a prescription drug experienced a side effect serious enough to send them to the doctor or hospital, but the majority of consumers don't know they can report these side effects to the FDA, which is responsible for tracking drug safety problems.
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Medicaid Prescriptions Go High-Tech
A new electronic system for the prescribing of medications will provide Medicaid physicians in Louisiana access to cutting-edge technology to provide safe an efficient prescribing services as well as help drive down medication costs.
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ARIKACE Effectively Penetrates Mucus, Biofilm, Kills Pseudomonas
Transave's ARIKACE may have the ability to penetrate mucus and biofilms, and decrease the number of Pseudomonas aeruginosa lung infections in patients with cystic fibrosis.
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Prasugrel Successfully Treats Stent Blood Clots
Prasugrel in combination with aspirin cuts the risk for developing blood clots in stents.
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FDA Identifies Requirements For Safety Plans For Certain Drugs, Biologics
FDA has identified 25 drugs and biologic products that will be required to submit safety plans called REMS.
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Pegintron, Rebetol Resulted In Higher SVR Than Flat Dosing
FDA has approved label revisions for Schering-Plough's PEGINTRON and REBETOL combination therapy for chronic hepatitis C, recommending weight-based dosing of REBETOL based on patient body weight.
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Independent Pharmacies Protecting You, Your Medications
With a renewed national spotlight on prescription drug abuse, especially among teenagers, it is important to note as well the often over-looked issue of crimes against pharmacies.
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