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Vol 62 - October 2009
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

FDA MedWatch Alerts

More FDA Medwatch Alerts

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