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Vol 53 - January 2009
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2008 - The Year in Drugs

January 2009
The year 2008 saw a number of advances in drug research and development, with many new drugs approved over a wide range of medical conditions. Latisse, Relistor, Cimzia, Pristiq, Vimpat and Sancuso were among the large number of drugs making their debut into the medical world in the past year. Read more...

New Drug Approvals

The following drugs have recently been approved by the FDA.

Gelnique (oxybutynin hydrochloride) Topical Gel
Date of Approval: January 27, 2009
Treatment for: Overactive Bladder
Gelnique Drug Information | Press Release

RiaSTAP (Fibrinogen Concentrate (Human))
Date of Approval: January 16, 2009
Treatment for: Congenital Fibrinogen Deficiency
RiaSTAP Drug Information | Press Release

Savella (milnacipran)
Date of Approval: January 14, 2009
Treatment for: Fibromyalgia
Savella Drug Information | Press Release

AllerNaze (triamcinolone acetonide) Nasal Spray
Date of Approval: January 7, 2009
Treatment for: Allergic Rhinitis
AllerNaze Drug Information | Press Release

Nexterone (amiodarone HCl) Injection
Date of Approval: December 24, 2008
Treatment for: Ventricular Fibrillation and Ventricular Tachycardia
Nexterone Drug Information | Press Release

Ryzolt (tramadol) Extended Release Tablets
Date of Approval: December 30, 2008
Treatment for: Pain
Ryzolt Drug Information | Press Release

Latisse (bimatoprost) Ophthalmic Solution
Date of Approval: December 24, 2008
Treatment for: Hypotrichosis of Eyelashes
Latisse Drug Information | Press Release

Degarelix for Injection
Date of Approval: December 24, 2008
Treatment for: Prostate Cancer
Degarelix Drug Information | Press Release

Zolpimist (zolpidem tartrate) Oral Spray
Date of Approval: December 19, 2008
Treatment for: Insomnia
Zolpimist Drug Information | Press Release

Epiduo (adapalene and benzoyl peroxide) Gel
Date of Approval: December 8, 2008
Treatment for: Acne
Epiduo 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.

Zingo (lidocaine hydrochloride monohydrate)
Patient Population Altered: January 8, 2009
Treatment for: Pain Associated with Venous Access Procedures in Adults
Zingo 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.

Stavudine Capsules
USP, 15 mg, 20 mg, 30 mg and 40 mg
Approved: December 29, 2008 Hetero Drugs Limited; Aurobindo Pharma Limited; Matrix Laboratories Limited
Generic for: Zerit Capsules

Stavudine for Oral Solution
USP, 1 mg/mL; (200 mL upon reconstitution)
Approved: December 29, 2008 Aurobindo Pharma USA, Inc.
Generic for: Zerit for Oral Solution

Letrozole Tablets
USP, 2.5 mg
Approved: December 24, 2008 Mylan Pharmaceuticals, Inc.
Generic for: Femara Tablets

Ibuprofen and Diphenhydramine Citrate Tablets
(OTC), 200 mg/38 mg
Approved: December 22, 2008 Perrigo R&D Company
Generic for: Advil PM Tablets

Gemcitabine for Injection
USP, 200 mg/single-use vial and 1 gram/single-use vial
Approved: December 18, 2008 Teva Parenteral Medicines, Inc.
Generic for: Gemzar for Injection

Acetazolamide Extended Release Capsules
500 mg
Approved: December 10, 2008 Zydus Pharmaceuticals USA Inc.
Generic for: Diamox Capsules 500 mg

Clobetasol Propionate Lotion
0.05%
Approved: December 4, 2008 Actavis Mid Atlantic LLC
Generic for: Clobex Topical Lotion

Other Drug News

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

Zoloft, Lexapro the Best of Newer Antidepressants
January 29, 2009
Sertraline (Zoloft) and escitalopram (Lexapro) are the best of 12 new-generation antidepressants, while reboxetine is the least effective, a new analysis shows. The Italian researchers reviewed 117 studies that included more than 25,000 patients with major depression to come to this conclusion.

Plavix Plus Heartburn Drugs May Hike Heart Risk
January 28, 2009
People taking the clot-preventing drug Plavix and an acid-reducing proton pump inhibitor medication after a heart attack have a dramatically higher risk of a second heart attack than those taking Plavix alone, a Canadian study finds.

Some Heart Failure Meds May Raise Fracture Risk in Women
January 27, 2009
The short-term use of heart failure drugs called loop diuretics does not appear to increase the risk of fractures in postmenopausal women, a new study finds, but their effect over the long term is less clear.

Hallucinations Are Rare Side Effects of ADHD Medications
January 26, 2009
Children who take medications for attention-deficit hyperactivity disorder (ADHD) may rarely experience some disturbing side effects, such as hallucinations.

Antidepressant Eases Anxiety in Older Adults
January 20, 2009
Older adults with generalized anxiety disorder treated with the antidepressant Lexapro showed significant improvement in symptoms, a new study reports.

Low-Cost Strategies to Maintain Health in Hard Times
January 19, 2009
Everyone needs to make sacrifices during hard economic times, but you don't have to shortchange your health.

Antacids Are Best First Choice for Indigestion
January 15, 2009
Starting treatment for dyspepsia -- the medical name for indigestion -- with run-of-the-mill antacids, then moving up to more sophisticated drugs if needed, is slightly less costly than starting with the more powerful drugs, a new study says.

Newer Contraceptives Don't Increase Heart Risk
January 15, 2009
Newer formulations of birth control pills don't seem to increase the risk of heart disease as much as older forms did, a new study says.

Meningitis Vaccine Seems to Work Like a Charm
January 14, 2009
Rates of pneumococcal meningitis, a potentially life-threatening infection, have declined substantially since a new vaccine was introduced in 2000, a new study shows.

Newer Antipsychotics Pose Cardiac Risk: Study
January 14, 2009
A new study warns that the second generation of antipsychotic drugs, used to treat conditions ranging from schizophrenia to anxiety, put patients at higher risk of sudden death due to cardiac arrest.

FDA Finds No Link So Far Between Asthma Drugs and Suicide Risk
January 14, 2009
An ongoing U.S. Food and Drug Administration safety review of possible suicidal behavior among those taking asthma drugs has found no evidence of a link so far.

Millions More Americans Might Be Placed on Statins
January 13, 2009
If doctors start taking results of a recent drug company-sponsored trial seriously, 11 million more older Americans might be taking cholesterol-lowering statin medications, experts say.

Certain Antidepressants Ease Fibromyalgia Symptoms
January 13, 2009
Antidepressants may help people living with the chronic pain of fibromyalgia experience fewer symptoms and improve their quality of life, new research shows.

More News Headlines

FDA MedWatch Alerts

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