Volume 35 - April 2007

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Feature: gets a Makeover

We've been working tirelessly over the last few months to improve the web site. As of April 1st, virtually everything has been upgraded and/or simplified. Even this newsletter has been redesigned for simplicity and speedier delivery. We've also added thousands of pages of new information. From consumer drug information, to natural product monographs to directly sourced FDA professional information.

If you haven't been to recently, you'll also notice a completely new design which follows the latest Web2.0 trends and greatly improves the user experience. Read the complete list of changes made in this update.


Latest News Headlines
The latest Pharmaceutical News & Articles brought to you by

Solvay Pharmaceuticals Files Tedisamil, a New Cardiometabolic Product for the Treatment of Atrial Fibrillation and Atrial Flutter
BRUSSELS, Belguim, April 25, 2007--Solvay announced today that its dossier for intravenous tedisamil (intended brand name: Pulzium IV), a new chemical entity coming from Solvay Pharmaceuticals R&D laboratories, has been filed for approval by the...

Wyeth Receives Approvable Letter from FDA for Bazedoxifene for the Prevention of Postmenopausal Osteoporosis
COLLEGEVILLE, Pa., April 24, 2007 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for bazedoxifene, a selective estrogen...

Pharmacyclics Announces FDA Filing of New Drug Application for Xcytrin Injection to Treat Lung Cancer Brain Metastases
SUNNYVALE, Calif., April 23, 2007 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has filed the company's New Drug Application (NDA) for Xcytrin (motexafin gadolinium) Injection....

Questions Over Zyprexa Clinical Trial Data Underscore Need for Congress to Act Now on Drug Safety Legislation
Senate vote could come next week on package of needed reforms WASHINGTON, April 25, 2007 /PRNewswire-USNewswire/ -- Today's news that the Food and Drug Administration is examining whether the maker of Zyprexa failed to submit clinical trial data...

Large Numbers of People Do Not Trust the Institutions They Identify as Most Responsible for Drug Safety
Many believe the FDA and pharmaceutical companies should bear the most responsibility for drug safety, but are skeptical that they can be trusted to do so ROCHESTER, N.Y., April 25, 2007 /PRNewswire/ -- In a survey conducted by Harris...

New Trial Expands Evidence for Glucobay in Prevention of Cardiovascular Diseases
BERLIN/BARCELONA, April 25, 2007 – On the occasion of the 2nd International Congress on Prediabetes and the Metabolic Syndrome held in Barcelona, Spain, April 25-28, 2007, the initiation of the Acarbose Cardiovascular Evaluation (ACE)...

Orion's Partner Discontinues Development of Levosimendan (Simdax) in the US
ESPOO, Finland, April 25, 2007-Orion has been informed by Abbott, the license holder for the intravenously administered formulation of levosimendan (trade name Simdax), an Orion-originated compound for acute decompensated heart failure, that Abbott...

New Indication for Singulair (montelukast sodium) Approved to Prevent Exercise-induced Bronchoconstriction
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Apr 25, 2007 - Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for SINGULAIR(R) (montelukast sodium) to prevent...

Novartis Expands Portfolio of Respiratory Medicines
Novartis expands portfolio of respiratory medicines by acquiring rights to a novel therapeutic vaccine against nicotine addiction Therapeutic vaccine CYT002-NicQb acquired from Cytos Biotechnology in worldwide licensing agreement - set to...

PhRMA Statement on Medicare Trustees Annual Report
WASHINGTON, April 24, 2007 — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement on the Medicare Trustees Annual Report: “The recently released Medicare Trustees...



Latest FDA Approvals
The following drugs have recently been approved by the FDA.

Influenza Virus Vaccine, H5N1 Injection
April 17, 2007 - Company: Sanofi Pasteur Inc.
Treatment for: Prevention of H5N1 Influenza (Avian Influenza)

Reclast (zoledronic acid) Infusion - formerly Aclasta
April 17, 2007 - Company: Novartis
Treatment for: Paget's Disease

Altabax (retapamulin) Ointment
April 12, 2007 - Company: GlaxoSmithKline
Treatment for: Impetigo

Janumet (sitagliptin and metformin) Tablets
March 30, 2007 - Company: Merck & Co., Inc.
Treatment for: Diabetes Mellitus Type II

Ceprotin (Protein C Concentrate (Human)) Injection
March 30, 2007 - Company: Baxter Healthcare Corporation
Treatment for: Severe Congenital Protein C Deficiency

Soliris (eculizumab) Injection
March 16, 2007 - Company: Alexion Pharmaceuticals, Inc.
Treatment for: Paroxysmal Nocturnal Hemoglobinuria (PNH)

Tykerb (lapatinib ditosylate) Tablets
March 13, 2007 - Company: GlaxoSmithKline
Treatment for: Advanced Breast Cancer, Breast Cancer



Latest FDA MedWatch Alerts
MedWatch alerts are concerning pharmaceuticals already released in the USA and are issued by the FDA.

Avastin (bevacizumab)
April 21, 2007 - Audience: Oncological and other healthcare professionals
Genentech and FDA notified healthcare professionals of important new safety information regarding tracheoesophageal (TE) fistula formation in a recent clinical study in...

Zanaflex (tizanidine hydrochloride) Tablets and Capsules
April 11, 2007 - Audience: Healthcare professionals
Acorda Therapeutics and FDA informed healthcare professionals of changes to the CONTRAINDICATIONS and WARNINGS Sections of the product labeling for Zanaflex, a drug used to treat spasticity. In...

Combivir (lamivudine and zidovudine) Tablets
April 10, 2007 - Audience: Pharmacists, other healthcare professionals
GlaxoSmithKline and FDA informed healthcare professionals of an apparent third-party tampering that resulted in the misbranding of Ziagen as Combivir and employed counterfeit...

Ziagen (abacavir sulfate) Tablets
April 10, 2007 - Audience: Pharmacists, other healthcare professionals
GlaxoSmithKline and FDA informed healthcare professionals of an apparent third-party tampering that resulted in the misbranding of Ziagen as Combivir and employed counterfeit...

Trimethobenzamide hydrochloride suppositories
April 06, 2007 - Audience: Healthcare professionals, consumers
FDA notified healthcare professionals and consumers that companies must stop manufacturing and distributing unapproved suppository drug products containing trimethobenzamide...

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Tools & helpful Links
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Pill Identifier - The Pill Identifier enables a search for unidentified pills by imprint code or shape/color.
Drug Interactions Checker - Increasingly popular as more healthcare professionals and consumers make the effort to seek detailed information on drug-drug and drug-food interactions.
Image Search - Clear photographic images of over 4,000 tablets and capsules searchable by drug name.
New Drugs - All the latest information on FDA Approvals and recent additions to the database.
News & Articles - Roundup of recent drug-related news and press releases. Also latest news from FDA MedWatch service including timely publication of recalls, withdrawals, warnings, and label/packaging changes.


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