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Featured News 1 Million More Doses of Swine Flu Vaccine on Hand
October 2009 U.S. officials reported Wednesday the addition of another million doses H1N1 swine flu vaccine, bringing the total so far to 23 million doses. Read more... New Drug Approvals
The following drugs have recently been approved by the FDA. Arzerra (ofatumumab) Injection Date of Approval: October 26, 2009 Treatment for: Chronic Lymphocytic Leukemia Arzerra Drug Information | Press Release Votrient (pazopanib) Tablets Date of Approval: October 19, 2009 Treatment for: Renal Cell Carcinoma Votrient Drug Information | Press Release Twynsta (telmisartan and amlodipine) Tablets Date of Approval: October 16, 2009 Treatment for: Hypertension Twynsta Drug Information | Press Release Cervarix (human papillomavirus bivalent (types 16 and 18) vaccine, recombinant) Injection Date of Approval: October 16, 2009 Treatment for: Human Papillomavirus Prophylaxis Cervarix Drug Information | Press Release Berinert (C1 esterase inhibitor (human)) Injection Date of Approval: October 9, 2009 Treatment for: Angioedema Berinert 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. Colcrys (colchicine) Tablets New Indication Approved: October 16, 2009 Now Approved for: Prevention of Gout Colcrys Drug Information | Press Release Micardis (telmisartan) Tablets New Indication Approved: October 16, 2009 Now Approved for: Cardiovascular Risk Reduction Micardis Drug Information | Press Release Gardasil (human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant) Injection New Indication Approved: October 16, 2009 Now Approved for: Prevention of Genital Warts Caused by HPV in Boys and Young Men Gardasil Drug Information | Press Release Mirena (levonorgestrel) Intrauterine System New Indication Approved: October 1, 2009 Now Approved for: Heavy Menstrual Bleeding in IUD Users Mirena Drug Information | Press Release Fluarix (influenza virus vaccine, inactivated) Patient Population Altered: October 19, 2009 Now Approved for: Children ages 3 years to 17 years Fluarix Drug Information | Press Release Elitek (rasburicase) Injection Patient Population Altered: October 16, 2009 Now Approved for: Adult Patients Elitek Drug Information | Press Release Crestor (rosuvastatin calcium) Tablets Patient Population Altered: October 15, 2009 Now Approved for: Pediatric Patients Crestor Drug Information | Press Release Welchol (colesevelam HCl) Tablets and Oral Suspension Patient Population Altered: October 2, 2009 Now Approved for: Pediatric Patients with Heterozygous Familial Hypercholesterolemia Welchol Drug Information | Press Release 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.
Norethindrone Acetate & Ethinyl Estradiol Tablets USP, & Fe 1 mg/0.02 mg with 75 mg Ferrous Fumarate (24-Day Regimen)
Approved: September 1, 2009 Watson Laboratotries, Inc.
Generic for: Loestrin 24 Fe Tablets Temazepam Capsules USP, 7.5 mg
Approved: September 8, 2009 Mutual Pharmaceutical Company, Inc.
Generic for: Restoril Capsules 7.5 mg Nateglinide Tablets 60 mg and 120 mg
Approved: September 9, 2009 Par Pharmaceutical, Inc.; Dr. Reddy's Laboratories; Teva Pharmaceuticals USA
Generic for: Starlix Tablets Piperacillin and Tazobactam for Injection 36 g (base)/4.5 g (base)/vial, (pharmacy bulk package)
Approved: September 15, 2009 Orchid Healthcare
Generic for: Zosyn for Injection (Pharmacy Bulk Package) Piperacillin and Tazobactam for Injection 2 g (base)/250 mg (base)/vial, 3 g (base)/375 mg (base)/vial and 4 g (base)/500 mg (base)/vial
Approved: September 15, 2009 Orchid Healthcare
Generic for: Zosyn for Injection Other Drug News
Mapping the Link Between Alcohol, Cancer
October 27, 2009 New research suggests that alcohol may boost the progression of cancer by stimulating a pathway inside cells.
Changing Behavior Helps Patients Take Medication as Prescribed
October 27, 2009 Oct. 26, 2009 –- Taking medication as
the doctor prescribes is crucial to improving health.
HPV Vaccine No More Painful Than Other Shots
October 23, 2009 There have been reports that injections of the human papillomavirus (HPV) vaccine are especially painful, but a new study finds that they don't hurt more than any other shots.
Drug Use in Teens May Damage Memory Years Later
October 22, 2009 Rats develop memory loss in adulthood after receiving high doses of amphetamines during their "teen" years, new research shows.
Worldwide Vaccine Availability Reaches All-Time High: Report
October 21, 2009 Worldwide immunization rates are at their highest-ever levels, a new report shows.
Full Results of AIDS Vaccine Trial Confirm Modest Benefit
October 20, 2009 The full results of a landmark trial of an AIDS vaccine show that the shot did have limited success in protecting recipients from HIV.
Drinking Your Way to Health? Perhaps Not
October 18, 2009 Just about every month - if not every week - a new study emerges touting the health benefits to be gained from a daily glass of wine or a pint of dark beer.
Bad Reaction No Good Reason to Avoid Future Shots
October 15, 2009 People who appear to be allergic to vaccinations shouldn't automatically avoid future immunizations, but instead should try to find out why they had a bad reaction, new guidelines say.
New FDA Web Page Lists Disposal Instructions for Select Medicines
October 15, 2009 The United States Food and Drug
Administration has launched a
Web page for consumers with information on how to dispose of
certain drugs, including several high-potency opioids and other
selected controlled substances.
Stop-Smoking Vaccine in the Works
October 12, 2009 The National Institute on Drug Abuse has given a $10 million grant to a Maryland company to help it in the final phases of research regarding a possible anti-nicotine vaccine.
In Health Care Today, It's Electronic All the Way
October 3, 2009 Imagine that you see a new mole and don't like the looks of it so you take a picture of it using your cell phone and e-mail it to your family doctor for an opinion.
Children Need Seasonal Flu Vaccine, Experts Say
October 1, 2009 U.S. health officials continue to stress the need to vaccinate children against seasonal flu, as well as swine flu. More News Headlines
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