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Vol 46 - June 2008
New User Reviews & Ratings
Featured News

Majority of Americans Support Legislative Action to Disclose Pharmaceutical Company Gifts to Physicians

June 18, 2008
A majority of Americans (64%) say that it is important to know their physician's financial ties to pharmaceutical companies and 68% would support legislation requiring pharmaceutical companies to disclose gifts to doctors, according to the results of a new survey released today by the Prescription Project. The pharmaceutical industry spends more than $7 billion annually marketing to physicians, much of that marketing in the form of free gifts - ranging from pens and meals to continuing medical education classes and lucrative speaking engagements.

New Drug Approvals

The following drugs have recently been approved by the FDA.

Durezol (difluprednate) Ophthalmic Emulsion
Date of Approval: June 23, 2008
Treatment for: Postoperative Ocular Inflammation
Durezol Drug Information | Press Release

PrandiMet (repaglinide and metformin) Tablets
Date of Approval: June 23, 2008
Treatment for: Diabetes Mellitus Type II
PrandiMet Drug Information | Press Release

Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine)
Date of Approval: June 20, 2008
Treatment for: Prophylaxis of Pertussis, Tetanus, Diphtheria, Poliomyelitis and Haemophilus influenzae
Pentacel Drug Information | Press Release

Trivaris (triamcinolone acetonide) Intravitreal Injection
Date of Approval: June 16, 2008
Treatment for: Ocular Inflammatory Conditions
Trivaris Drug Information | Press Release

Entereg (alvimopan) Capsules
Date of Approval: May 20, 2008
Treatment for: Postoperative Ileus
Entereg Drug Information | Press Release

More FDA Approvals

New Indications and Dosage Forms

Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens.

Aptivus (tipranavir) Oral Solution
New Dosage Form Approved: June 23, 2008
Treatment for: Treatment-Experienced Pediatric, Adolescent and Adult HIV Patients
Aptivus Drug Information | Press Release

Velcade (bortezomib) Injection
New Indication Approved: June 20, 2008
Treatment for: Previously Untreated Multiple Myeloma
Velcade Drug Information | Press Release

Avodart (dutasteride) Capsules
New Indication Approved: June 19, 2008
Treatment for: Symptomatic Enlarged Prostate in Combination with Tamsulosin
Avodart Drug Information | Press Release

Requip XL (ropinirole) Extended-Release Tablets
New Formulation Approved: June 13, 2008
Treatment for: Parkinson's Disease
Requip XL Drug Information | Press Release

Cymbalta (duloxetine) Delayed-Release Capsules
New Indication Approved: June 13, 2008
Treatment for: Fibromyalgia
Cymbalta Drug Information | Press Release

Reclast (zoledronic acid) Injection
New Indication Approved: June 3, 2008
Treatment for: Prevention of Fractures
Reclast 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.

Ropinirole Hydrochloride Tablets
0.25 mg (base), 0.5 mg (base), 1 mg (base), 2 mg (base), 3 mg (base) and 4 mg (base)
Approved: May 5, 2008 Mylan Pharmaceuticals, Inc.; Roxane Laboratories, Inc.
Generic for: Requip Tablets

Calcipotriene Topical Solution
0.005% (Scalp Solution)
Approved: May 6, 2008 Nycomed US, Inc.
Generic for: Dovonex Scalp Solution, 0.005%

Acarbose Tablets
25 mg, 50 mg, and 100 mg
Approved: May 7, 2008 Roxane Laboratories, Inc.; Cobalt Laboratories
Generic for: Precose Tablets

Drospirenone and Ethinyl Estradiol Tablets
3 mg/0.03 mg; (28-day regimen)
Approved: May 9, 2008 Barr Laboratories, Inc.
Generic for: Yasmin Tablets

Fluoxetine Capsules
USP 10 mg and 20 mg
Approved: May 20, 2008 Teva Pharmaceuticals USA
Generic for: Sarafem Pulvules

Cetirizine Hydrochloride Syrup
1 mg/mL (Rx only)
Approved: May 27, 2008 Teva Pharmaceuticals USA
Generic for: Zyrtec Syrup (Rx only)

Omeprazole Delayed-Release Capsules
USP, 40 mg
Approved: May 30, 2008 Andrx Pharmaceuticals, LLC
Generic for: Prilosec Delayed-Release Capsules 40 mg

Other Drug News

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

Savings Help the Medicine Go Down
June 24, 2008
A new study of state-subsidized pharmacy assistance programs showed that providing prescription drug coverage for low-income seniors reduces Medicaid and Medicare costs. Moreover, needy seniors enrolled in the programs were able to cut their dose skimping and nursing home admissions in half, according to the Brandeis University research.

Federal Action Needed to Fill Antibiotic Pipeline, Says the Alliance for the Prudent Use of Antibiotics
June 24, 2008
Antibiotic resistance is one of the major public health threats of the 21st century and the focus of today's Senate hearing, Emergence of the Superbug: Antimicrobial Resistance in the US. Resistant infections pose a threat to US healthcare's reliance on high tech medicine. Resistant bacteria also represent a potential resource for adversaries to exploit in building biological weapons.

Patient's Own Infection-Fighting T Cells Put Late-Stage Melanoma Into Long-Term Remission - Without Chemotherapy or Radiation
June 18, 2008
Researchers describe the first successful use of a human patient's cloned infection-fighting T cells as the sole therapy to put an advanced solid-tumor cancer into long-term remission. A team led by Cassian Yee, M.D., an associate member of the Clinical Research Division at Fred Hutchinson Cancer Research Center, reports these findings in the June 19 issue of the New England Journal of Medicine.

FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'
June 17, 2008
Warning Letters have been sent to 23 U.S. companies and two foreign individuals marketing a wide range of products fraudulently claiming to prevent and cure cancer, according to the U.S. Food and Drug Administration today. The FDA also warns North American consumers against using or purchasing the products, which include tablets, teas, tonics, black salves, and creams, and are sold under various names on the Internet.

Low HDL Cholesterol from Gene Variation Not Associated with Increased Risk of Ischemic Heart Disease
June 3, 2008
Lower levels of high-density lipoprotein (HDL) cholesterol due to a gene mutation is not associated with an increased risk of ischemic heart disease, according to a study in the June 4 issue of JAMA.

TCH Treatment Approved for HER2 Positive Early Breast Cancer
May 29, 2008
The Cancer International Research Group (CIRG), a division of TRIO (Translational Research in Oncology) announced today that, based on its study BCIRG 006, the U.S. Food and Drug Administration (FDA) has approved a new treatment consisting of the chemotherapeutic agents Taxotere (docetaxel) and carboplatin combined with Herceptin (trastuzumab) (TCH) for the adjuvant (post-surgery) treatment of HER2 (Human Epidermal growth factor Receptor 2)-positive early breast cancer.

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