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Vol 67 - March 2010
Featured News

To Supplement or Not to Supplement?

March 2010
You know you should eat better - but that daily multivitamin pill, calcium supplements and possibly others compensate, right? Perhaps. Read more...

New Drug Approvals

The following drugs have recently been approved by the FDA.

Zyclara (imiquimod) Cream
Date of Approval: March 25, 2010
Treatment for: Actinic Keratosis
Zyclara Drug Information | Press Release

Silenor (doxepin) Tablets
Date of Approval: March 17, 2010
Treatment for: Insomnia
Silenor Drug Information | Press Release

Carbaglu (carglumic acid) Tablets
Date of Approval: March 18, 2010
Treatment for: NAGS Deficiency Hyperammonemia
Carbaglu Drug Information | Press Release

Hizentra (immune globulin subcutaneous (human)) Liquid
Date of Approval: March 4, 2010
Treatment for: Primary Immunodeficiency Syndrome
Hizentra Drug Information | Press Release

Exalgo (hydromorphone) Extended Release Tablets
Date of Approval: March 1, 2010
Treatment for: Pain in Opioid Tolerant Patients
Exalgo 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.

Norditropin (somatropin [rDNA origin]) Injection
New Dosage Form Approved: March 1, 2010
Now Approved: Norditropin FlexPro
Norditropin Drug Information | Press Release

Dacogen (decitabine) for Injection
New Dosage Regimen: March 11, 2010
Now Approved: Five-Day Dosing Regimen
Dacogen Drug Information | Press Release

Differin (adapalene)
New Formulation Approved: March 17, 2010
Now Approved: Differin Lotion
Differin Drug Information | Press Release

Trelstar (triptorelin pamoate) Injection
New Formulation Approved: March 10, 2010
Now Approved: Trelstar 22.5 mg 6-Month Formulation
Trelstar Drug Information | Press Release

Xifaxan (rifaximin) Tablets
New Indication Approved: March 24, 2010
Now Approved for: Hepatic Encephalopathy
Xifaxan Drug Information | Press Release

Mirapex (pramipexole dihydrochloride)
New Indication Approved: March 19, 2010
Now Approved: Mirapex ER for Both Early and Advanced Parkinson's Disease
Mirapex Drug Information | Press Release

Botox (onabotulinumtoxinA) Injection
New Indication Approved: March 9, 2010
Now Approved for: Upper Limb Spasticity
Botox 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.

Desloratadine Tablets 5 mg
Approved: February 19, 2010 Company: Orchid Healthcare
Generic for: Clarinex Tablets

Imiquimod Cream 5%
Approved: February 25, 2010 Company: Nycomed US, Inc.
Generic for: Aldara Cream

Other Drug News

Asclera Approved to Treat Varicose Veins
March 31, 2010
Polidocanol (Asclera) has been approved by the Food and Drug Administration to treat small varicose veins, the agency said in a news release.

Many Kids Not Fully Informed of Their Role in Cancer Studies
March 30, 2010
Among children with cancer who are enrolled in clinical research trials, most do not receive a clear explanation of their role in research from their parents and doctors, a new report suggests.

Optimism May Boost Immune System
March 25, 2010
An optimistic outlook might strenghten your body's ability to fight off infection, new research suggests.

Topical Drugs May Pollute Waterways
March 25, 2010
Showers and baths are potential sources of hormones, antibiotics and other medicines that pollute water, a new study shows.

Abbreviated Trials Yield Misleading Results: Study
March 23, 2010
Many positive treatment effects are exaggerated in clinical trials that are stopped early due to encouraging results, a new study has found.

Light Drinking Good for the Heart
March 22, 2010
Two major studies confirm the current medical consensus that moderate drinking appears to be good for the heart but heavy drinking is bad for health in general.

Pesticide Labels Too Vague
March 22, 2010
Labels on some common household pesticide products lack clear information about how to use them safely, a new study shows.

Measles Outbreak Triggered by Unvaccinated Child
March 22, 2010
What began as a family trip to Switzerland in 2008 ended up as a public health nightmare in California.

FDA Asks Consumers To Submit Questions As Part Of Transparency Plan
March 18, 2010
So how and when does the Food and Drug Administration decide to pull a prescription from the market? Should I be asking whether my doctor accepts gifts or sandwiches from drug companies? Why are drug makers notified by the FDA when a device is harmful before the general public? Questions like these from consumers can be posed to the FDA as part of an effort to make the agency more open and less arcane to the general public, as well as the health care providers and companies it regulates, the agency said.

Blood Vessels Bounce Back Once Smokers Quit
March 16, 2010
Blood vessel function rapidly recuperates after smokers kick the habit, leading to a reduced risk of heart disease and heart attack, new research shows.

Medicine's Future Could Lie in Each Patient's Genome
March 11, 2010
Two separate scientific teams announced this week that they had successfully sequenced individual genomes to pinpoint precise genetic causes of illness - breakthroughs that open the door to a future of individualized, genomics-based medicine.

Kids Who Get Flu Shots Protect the Unvaccinated
March 9, 2010
Children who get a flu shot help prevent flu from spreading in their communities, Canadian researchers say.

Parents Still Worried About Vaccine Safety
March 1, 2010
Although most American parents vaccinate their children, many are concerned about the safety of vaccines and some choose not to have their children protected from potentially deadly diseases, a new study found.

More News Headlines

FDA MedWatch Alerts

More FDA Medwatch Alerts

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