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Vol 56 - April 2009
Mobile Edition for Consumers
Featured News

U.S. Declares Public Health Emergency in Response to Swine Flu

April 2009
U.S. health officials have declared a public health emergency Sunday in response to the swine flu outbreak, as the number of confirmed cases nationwide rose to 20. Read more...

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New Drug Approvals

The following drugs have recently been approved by the FDA.

Simponi (golimumab) Injection
Date of Approval: April 24, 2009
Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
Simponi Drug Information | Press Release

Benzyl Alcohol Lotion 5%
Date of Approval: April 9, 2009
Treatment for: Head Lice
Benzyl Alcohol Lotion 5% Drug Information | Press Release

Coartem (artemether and lumefantrine) Tablets
Date of Approval: April 7, 2009
Treatment for: Malaria
Coartem Drug Information | Press Release

Ixiaro (Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed)
Date of Approval: March 30, 2009
Treatment for: Japanese Encephalitis Virus Prophylaxis
Ixiaro Drug Information | Press Release

Afinitor (everolimus) Tablets
Date of Approval: March 30, 2009
Treatment for: Renal Cell Carcinoma
Afinitor 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.

Carbamazepine Extended-Release Tablets
USP 100 mg, 200 mg and 400 mg
Approved: March 31, 2009 Taro Pharmaceuticals USA, Inc.
Generic for: Tegretol XR Tablets
Treatment for: Epileptic Seizures and Trigeminal Neuralgia

Drospirenone and Ethinyl Estradiol Tablets
3 mg/0.02 mg (28-Day Regimen)
Approved: March 30, 2009 Barr Laboratories, Inc.
Generic for: Yaz Tablets
Treatment for: Birth Control and Premenstrual Dysphoric Disorder

Topiramate Tablets
25 mg, 50 mg, 100 mg and 200 mg
Approved: March 27, 2009 Torrent Pharmaceuticals Limited; Ranbaxy Laboratories Limited (not 50 mg); Par Pharmaceutical, Inc.; Cipla Limited; Mylan Pharmaceuticals Inc.; Apotex Inc.; Cobalt Laboratories; Glenmark Generics Limited; Roxane Laboratories, Inc.; Barr Laboratories, Inc. (not 50 mg); Sun Pharmaceutical Industries, Ltd.; Invagen Pharmaceuticals, Inc.; Aurobindo Pharma Limited; Unichem Laboratories Limited (not 200 mg); Zydus Pharmaceuticals USA, Inc.; Teva Pharmaceuticals USA
Generic for: Topamax Tablets
Treatment for: Seizures and Prevention of Migraine Headaches

Ibuprofen Capsules, 200 mg
(Liquid Filled Capsule) (OTC)
Approved: March 24, 2009 Banner Pharmacaps, Inc.
Generic for: Advil Liqui-Gels Capsules
Treatment for: Aches and Pains

Levalbuterol Inhalation Solution
USP, (Concentrate) 0.25% (1.25 mg/0.5mL)
Approved: March 20, 2009 Dey LP
Generic for: Xopenex Inhalation Solution (Concentrate)
Treatment for: Asthma

Liothyronine Sodium Tablets
USP 5 mcg, 25 mcg, and 50 mcg
Approved: March 20, 2009 Coastal Pharmaceuticals
Generic for: Cytomel Tablets
Treatment for: Hypothyroidism

Apraclonidine Ophthalmic Solution
USP 0.5% (base)
Approved: March 12, 2009 Akorn, Inc.
Generic for: Iopidine Ophthalmic Solution, 0.5%
Treatment for: Increased Intraocular Pressure

Malathion Lotion
USP 0.5%
Approved: March 6, 2009 Synerx Pharma, LLC
Generic for: Ovide Lotion, 0.5%
Treatment for: Head Lice

Other Drug News

The latest Pharmaceutical News & Articles brought to you by Drugs.com

FDA Approves 'Plan B' Pill for 17-Year-Olds
April 22, 2009
Responding to a federal judge's directive, the U.S. Food and Drug Administration said Wednesday that it will now allow 17-year-olds to get the controversial "morning-after" birth control pill without a doctor's prescription.

Addiction Drug May Help Ease Fibromyalgia
April 17, 2009
Low doses of an inexpensive drug called naltrexone -- already used for years to treat drug addiction -- helped reduce pain and fatigue in women with the painful disorder fibromyalgia, a new study has found.

Birth Control Pills Linked to Lupus Risk
April 9, 2009
Women taking birth control pills, especially those who have just started taking them, may face an increased risk of developing the autoimmune disease lupus, a new study suggests.

Acid Reducers May Not Help All With Asthma
April 8, 2009
Acid-suppressing medications won't ease asthma symptoms if you don't have heartburn symptoms, too, a new study has found.

New Prostate Cancer Drug May Hold Promise
April 7, 2009
A new drug with a radically different way of attacking prostate cancer has done well in an initial trial and is ready for larger-scale testing, researchers report.

Certain Diabetes Drugs May Pose Eye Risk
April 7, 2009
A class of diabetes drugs called glitazones are associated with an increased risk of a vision-threatening complication called diabetic macular edema (DME), which features swelling and fluid accumulation in the retina.

Plain-Language Guides Detail Insulin Treatments
April 2, 2009
New "plain language" guides from the federal government spell out the differences between available treatments for type 2 diabetes for patients and doctors alike.

Many Smokers Don't Tell Docs About Their Habit
April 2, 2009
More than half of smokers aren't fretting over their personal health, and almost a quarter of those who have health-care providers haven't discussed their tobacco use with that person, a new online survey shows.

More News Headlines

FDA MedWatch Alerts

More FDA Medwatch Alerts

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