| Featured News Monthly Roundup - August 2011 August 2011 While most of us are lazily wrapping up our summer vacations, the FDA busily approved six new drugs and one new drug device in August. Targeted oncology therapies are making headlines, and Xalkori and Zelboraf are leading the pack. Firazyr is now conveniently available for hereditary angioedema patients as a self-injection, and accelerated review of Adcetris provides new hope for lymphoma patients. Rounding out the approvals for the summer are: Propel, an implant that delivers local doses of the antiinflammatory mometasone for chronic sinusitis, and Complera, a triple drug, once-a-day HIV combo. Finally, looking ahead to next summer's camping trip, I am glad Anascorp is approved - the first scorpion antivenom on the market. Read more... New Drug Approvals The following drugs have recently been approved by the FDA. 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. Fondaparinux Sodium Injection
2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL and 10 mg/0.8 mL
Approved: July 11, 2011 - Dr. Reddy's Laboratories Limited Generic for: Arixtra FDA Drug Safety Labeling Changes This is a summary of the FDA drug labeling changes for July 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 | Epogen/Procrit
(epoetin alfa) and Aranesp (darbepoetin alfa) | x | - | x | x | - | - | - | - | Dostinex
(cabergoline) Tablets | - | x | x | - | - | - | - | - | Nitrostat
(nitroglycerin, USP) Sublingual Tablets | - | x | - | x | - | x | - | - | Paxil
(paroxetine HCl) tablets, oral solution and Paxil CR tablets | - | x | - | x | - | - | - | - | Ranexa
(Ranolazine) Extended-Release Tablets | - | x | x | x | - | - | - | - | Rotavirus Vaccine, Live, Oral, Pentavalent
(RotaTeq) | - | x | - | - | - | x | - | - | Arava
(leflunomide) Tablets | - | - | x | x | - | - | - | - | Bentyl
(dicyclomine hydrochloride, USP) Capsules/Tablets, Oral Syrup, Injection | - | - | x | x | - | - | - | - | Chantix
(varenicline) Tablets | - | - | x | x | x | - | - | - | Flomax
(tamsulosin hydrochloride) Capsules | - | - | x | x | - | - | - | - | Gilenya
(fingolimod) capsules 0.5 mg | - | - | x | x | - | - | - | - | Kenalog-10
(triamcinolone acetonide) Injection Kenalog-40 (triamcinolone acetonide) Injection | - | - | x | - | x | - | - | - | Micardis
(telmisartan) Tablets | - | - | - | x | - | - | - | - | Prograf
(tacrolimus) Capsules, Injection | - | - | x | x | x | - | - | - | Seroquel
(quetiapine fumarate) Tablets Seroquel (quetiapine fumarate) XR | - | - | x | x | x | - | - | - | Tev-Tropin
(somatropin [rDNA origin]) for injection | - | - | x | x | x | - | - | - | Truvada
(emtricitabine/tenofovir disoproxil fumarate) tablets | - | - | x | x | - | - | - | - | Zegerid OTC
(omeprazole 20mg and sodium bicarbonate 1100 mg) capsules | - | - | x | - | - | - | - | - | Cordran
(flurandrenolide, USP) Lotion | - | - | - | x | x | - | - | - | Creon
(pancrelipase) delayed-release capsules | - | - | - | x | x | - | - | - | | | - | - | - | x | - | - | - | - | Mobic
(meloxicam) Tablets, Oral Suspension | - | - | - | x | - | - | - | - | Spiriva HandiHaler
(tiotropium bromide inhalation powder) | - | - | - | x | - | - | - | - | Wellbutrin XL
(bupropion hydrochloride) Extended-Release Tablets Aplenzin (bupropion hydrobromide) Extended-Release Tablets | - | - | - | x | - | - | - | - | Wellbutrin
(bupropion hydrochloride) Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets | - | - | - | x | - | - | - | - | Coreg
(carvedilol) Tablets Coreg CR (carvedilol phosphate) Extended Release Capsules | - | - | - | - | x | - | - | - | Flovent HFA
(fluticasone propionate) Inhalation Aerosol | - | - | - | - | x | - | - | - | Ortho Evra
(norelgestromin and ethinyl estradiol) transdermal system | - | - | - | - | x | x | - | - | Actiq
(fentanyl citrate) oral transmucosal lozenge | - | - | - | - | - | - | - | - | Colcrys
(colchicine) Tablets | - | - | - | - | - | - | - | - | Fentora
(fentanyl buccal tablets) | - | - | - | - | - | - | - | - | Tikosyn
(dofetilide) Capsules | - | - | - | - | - | - | - | - | 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 U.S.-Mandated Report Finds Vaccines Safe for Kids August 25, 2011 An exhaustive new report from experts at the Institute of Medicine finds that children's vaccines are typically safe, with bad reactions occurring only rarely and then not causing any lasting medical problems. Don't Skip This Year's Flu Shot: CDC August 18, 2011 The 2011-12 flu vaccine protects against seasonal flu and H1N1, just like last year's, but that doesn't mean it's OK to skip your yearly flu shot, researchers from the Centers for Disease Control and Prevention warn. Kids Benefit From Flu Vaccine via Shot or Spray, Study Finds August 18, 2011 Children younger than 3 years old receive roughly the same amount of protection from the flu vaccine regardless of which method (injection, nasal spray, or one of each) is used to give the two recommended doses to them, according to a new federal study. New Uses Found for Old Drugs August 17, 2011 Many drugs already approved to combat certain illnesses may also be helpful in treating a slew of other seemingly unrelated health problems, a new study indicates. Americans' Use of Antidepressants On the Rise: Study August 4, 2011 Americans are popping more antidepressants than ever before to deal with everyday stress, and non-psychiatrists are increasingly willing to prescribe the drugs to patients with no mental health diagnosis, a new study finds. | | | 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 |
