| Monthly Roundup July 2011 We know it's still summer, but don't forget: those flu shots are due to be renewed each fall. In preparation, the FDA revealed the 2011-2012 flu vaccine strains this month. Heart disease patients take note: chronic and long-term NSAID use may be risky, so ask your doctor. The Institute of Medicine caught our attention by recommending free preventive services, including birth control, for women. In a safety update, the FDA warned consumers about error-prone acetaminophen dosing in children and McNeil announced new maximum doses for Tylenol. Finally, a flood of upcoming drug patent expirations should help save money for the US consumer. Read the full roundup here... New Drug Approvals The following drugs have recently been approved by the FDA. Date of Approval: July 1, 2011 Treatment for: Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery, Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery Xarelto Drug Information | Press Release New Indications and Dosage Forms Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. First-Time Generic Approvals First Time Generics are those drug products that have never been approved before as generic drug products and are new generic products to the marketplace. Levofloxacin Injection
25 mg/mL; packaged in 500 mg/20 mL and 750 mg/30 mL Single-Use Vials
Approved: June 20, 2011 - Akorn, Inc.; Sagent Strides, LLC Generic for: Levaquin Injection Levofloxacin Tablets
250 mg, 500 mg and 750 mg
Approved: June 20, 2011 - Aurobindo Pharma Limited; Sandoz, Inc.; Mylan Pharmaceuticals, Inc.; Teva Pharmaceuticals USA; Dr. Reddy's Laboratories Limited; Torrent Pharmaceuticals; Wockhardt Limited; Glenmark Generics Ltd. Generic for: Levaquin Tablets Sumatriptan Succinate Injection
6 mg (base)/0.5 mL; packaged in a Single-Dose Syringe With Autoinjector
Approved: June 21, 2011 - Sun Pharma Global FZE Generic for: Imitrex Statdose System Flucytosine Capsules
USP, 250 mg and 500 mg
Approved: June 28, 2011 - Sigmapharm Laboratories, LLC Generic for: Ancobon FDA Drug Safety Labeling Changes This is a summary of the FDA drug labeling changes for May 2011. Click on a drug name to view the changes in more detail. | Key to Label Sections: | | BW - Boxed Warning | C - Contraindications | | W - Warnings | P - Precautions | | AR - Adverse Reactions | PPI - Patient Package Insert | | MG - Medication Guide | PCI - Patient Counseling Information |
| | Sections Modified | | Drug Name | BW | C | W | P | AR | PPI | MG | PCI | Imuran
(azathioprine) Tablets and Injection | x | - | x | - | x | - | - | - | Biaxin Filmtab
(clarithromycin tablets, USP)Biaxin XL Filmtab (clarithromycin extended-release tablets)Biaxin Granules (clarithromycin for oral suspension, USP) | - | x | x | - | x | - | - | - | Afinitor
(everolimus) Tablets | - | - | x | x | - | - | - | - | Aldactazide
(spironolactone/hydrochlorothiazide) Tablets | - | - | x | - | - | - | - | - | Avandia
(rosiglitazone maleate)Avandamet (rosiglitazone maleate/metformin hydrochloride)Avandaryl (rosiglitazone maleate/glimepiride) Tablets | - | - | x | x | - | - | - | - | Benicar HCT
(olmesartan medoxomil/hydrochlorothiazide) Tablets | - | - | x | - | - | - | - | - | Genotropin
(somatropin [rDNA origin] for Injection | - | - | x | x | x | - | - | - | Humalog
(insulin lispro [rDNA origin]) Injection | - | - | x | x | - | - | - | - | Levatol
(penbutolol sulfate) Tablets | - | - | x | x | - | - | - | - | Micardis HCT
(telmisartan/hydrochlorothiazide) Tablets | - | - | x | x | - | - | - | - | Norditropin Cartridges
(somatropin [rDNA origin] injection) | - | - | x | x | x | - | - | - | Purinethol
(mercaptopurine) Tablets | - | - | x | - | - | - | - | - | Seroquel XR
(quetiapine fumarate) Extended-Release | - | - | x | x | - | - | - | - | Seroquel
(quetiapine fumarate) Tablets | - | - | x | x | - | - | - | - | Sutent
(sunitinib malate) Capsules | - | - | x | x | x | - | - | - | Teveten HCT
(eprosartan mesylate/hydrochlorothiazide) Tablets | - | - | x | x | - | - | - | - | Uniretic
(moexipril hydrochloride/hydrochlorothiazide) | - | - | x | - | - | - | - | - | Zegerid
(omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension | - | - | x | x | x | - | - | - | Ziac
(bisoprolol fumarate/hydrochlorothiazide) Tablets | - | - | x | - | - | - | - | - | Azor
(amlodipine and olmesartan medoxomil) Tablets | - | - | - | x | x | - | - | - | Capoten
(captopril) Tablets | - | - | - | x | - | - | - | - | Exforge
(amlodipine/valsartan) Tablets | - | - | - | x | - | - | - | - | Lexiva
(fosamprenavir calcium) Tablets and Oral Suspension | - | - | - | x | - | - | - | - | Teveten
(eprosartan mesylate) Tablets | - | - | - | x | - | - | - | - | Valturna
(aliskiren/valsartan) Tablets | - | - | - | x | - | - | - | - | Benicar
(olmesartan medoxomil) Tablets | - | - | - | - | x | - | - | - | Vibramycin
(doxycycline monohydrate) Oral Suspension | - | - | - | - | x | - | - | - | Vibra-Tabs
(doxycycline hyclate) | - | - | - | - | x | - | - | - | Foradil Aerolizer
(formoterol fumarate inhalation powder) | - | - | - | - | - | - | - | - | Note: the drug safety labeling changes listed above may not be a complete list. Please visit the link below for the entire current list and historical archive. Other Drug News CDC Issues Guidance for Coping With Lingering Heat July 25, 2011 Residents still struggling with extreme hot weather in the Midwest, South and East Coast need to make sure they stay cool and hydrated to prevent heat illnesses and injuries such as heat exhaustion and heat stroke, federal health officials said Monday. Are Newer MS Drugs Worth Their High Price Tag? July 21, 2011 Newer "biologic" drugs for multiple sclerosis do benefit some patients, a new study finds, but they are extraordinarily expensive and may not be cost-effective when compared to more basic treatments. U.S. Panel Recommends Free Coverage of Birth Control July 19, 2011 Women in the United States could have their birth control covered by insurance companies, free of co-pays, if provisions of a new report are enacted as part of last year's landmark health-reform law. FDA Unveils Flu Vaccines for 2011-12 Season July 18, 2011 Influenza may be far from most Americans' thoughts as much of the nation wilts under oppressive heat, but the FDA has announced it is already preparing for the 2011-12 flu season. Delving Into the Mystery of Placebos July 13, 2011 A new study finds that the power of the placebo effect left asthma patients thinking that real and fake drugs were doing the same level of good, even though the real medication actually had a much greater physical effect on their lungs. Drugs May Prevent HIV Spread Among Heterosexuals July 13, 2011 Giving antiretroviral drugs to heterosexuals at high risk of HIV infection can significantly reduce the chance they will develop the AIDS-causing virus, two new studies suggest. | | | FDA MedWatch Alerts  Tools & Helpful Links Medical Encyclopedia Use this feature to find information on diseases, symptoms, injuries, medical tests and surgical procedures. Pill Identifier The Pill Identifier enables a search for unidentified pills by imprint code or shape/color. Drug Interactions Checker Increasingly popular as more healthcare professionals and consumers make the effort to seek detailed information on drug-drug and drug-food interactions. New Drugs All the latest information on FDA Approvals and recent additions to the database. News & Articles Roundup of recent drug-related news and press releases. also latest news from FDA Medwatch service including timely publication of recalls, withdrawals, warnings, and label/packaging changes. About This Newsletter Drugs.com is not affiliated with any pharmaceutical company. We are dedicated to providing consumers and health professionals with objective information about prescription-medication discoveries and side effects. This information is not intended to be medical advice. You should contact your physician before making any changes to your health care. Drugs.com is not responsible for content provided by third-party web sites. About Your Subscription Your Feedback We always appreciate feedback so if you wish to give us your comments/ praise/ rebuke please Contact Us. Thanks so much for your continued support! The Editorial Team Drugs.com |
