PTCommunity News January 2004

Type 2 Diabetes Drug Naturlose To Enter Phase 3 Clinical Trial
FDA Approves New Indication for Ertapenem for Foot Infection in Diabetic Patients without Osteomyelitis
FDA and CDC Issue Alert on Menactra Meningococcal Vaccine and Guillain Barre Syndrome
European Union Grants Virulizin Orphan Drug Status
Phase 2 Pramlintide Obesity Trial Demonstrates Weight Loss in Obese Patients
Rosuvastatin Study Raises Safety Issues
’No Compelling Evidence’ of Prostate Cancer, Heart Disease Risk Found in Study of Testosterone Replacement Therapy
Managing the Treatment Costs of Multiple Sclerosis in a Managed Care Setting
FDA Requests Additional Study for Diquafosol Review
Phase III Results of Ovine Hyaluronidase Trial Show Reduction in Hemorrhage Density Compared to Control Group
FDA Issues Approvable Letter for Nasal Calcitonin Osteoporosis Agent
Phase III Studies for Once-Daily Tramadol Yield Positive Results
Phase III Maintenance Trial of Natalizumab Meets its Primary Endpoint
Mixed Results Reported for Phase II Eculizumab Trial
Researchers Add New Drug Prophylactic Option Against Flu
Statins, ACE Inhibitors Can Save Lives and Limbs, But Many Patients Go Without Them
Supplemental NDA Requests Changes in Ziprasidone Label
Zoderm, Prescription Acne Treatment, Now Available
European Regulators Grant Sildenafil Orphan Drug Designation for Possible Treatment of Pulmonary Arterial Hypertension
Rolling NDA Submitted for Rubitecan, Potential Pancreatic Cancer Treatment
Joint Panel Urges Screening and Monitoring of Patients Using Second- Generation Antipsychotics
NDA Filed for Timolol, Travoprost Combination To Treat Glaucoma
Modafinil Indication Expanded To Include Treatment for Apnea, Shift Work Sleep Disorder
FDA Extends Review of Anidulafungin NDA an Additional 90 Days
FDA Approves Metoprolol Tartrate in New 25mg Dose
Bortezomib Recommended for European Marketing Approval
Endometriosis Treatment FP1096 Reduced Symptoms in Phase II Trial
Phase II Clinical Trials Initiated for XMP.629, Potential Acne Treatment
Phase II Study Results Show Angioedema Symptoms Resolve Rapidly With Icatibant
Phase II Study of Interferon Gamma-1b Fails to Meet Primary Endpoint of Reversal of Fibrosis
"Rolling" NDA Submitted for Erlotinib in Non-Small Cell Lung Cancer
Combination of Memantine, Donepezil More Effective Than Donepezil Alone
FDA Approves Liquid Form of Cytarabine
Azithromycin Approved as Once-Daily, Three-Day Treatment for Acute Bacterial Sinusitis
Ribavirin Oral Solution Now Available for Treating Pediatric Patients With Hepatitis C
Etanercept Approved by European Union for the Treatment of Ankylosing Spondylitis
Supplemental NDA Submitted for Oxaliplatin as Adjuvant Treatment for Colon Cancer
Phase III Study Demonstrates Sebazole Is More Effective Than Seboride
FDA Recaps Approvals in 2003, Expects Faster Approvals in the Future
Generic Bupropion HCl Sustained Release Tablets Launched
Eflornithine Does Not Improve Outcome in Superficial Bladder Cancer
Beta Blockers Cost Effective to Society for Heart Failure Treatment
Study Shows Patients at Risk for Deep Vein Thrombosis Do Not Receive Preventive Medications
Study Finds Linezolid Effective for Diabetic Foot Infections
Independent Review Board Recommends Phase II/III Study To Continue of Fibrillex in Amyloid A Amyloidosis
Phase II Study Design Approved by FDA for New Colon Cleansing Tablet
NDA Submitted for Mesalamine Suppositories for the Treatment of Ulcerative Proctitis
Expanded Indication for Lamotrigine Includes Monotherapy Treatment for Adults With Partial Seizures
FDA Approves Olanzapine for Maintenance of Bipolar Disorder
Highlights from January/February issue of <i>JMCP</i>
Phase III Alvimopan Results Fail To Show Significant Benefit in Postoperative Ileus
Approvable Letter Issued for Valproate NDA
Second Phase III Efficacy Study Completed for SPI-0211, Treatment for Constipation
FDA Approves Quetiapine for Treatment of Acute Mania Associated With Bipolar Disorder
Phase III Trials Initiated for the R-Isomer of Modafinil
Second Phase III Trial Initiated of Methylnaltrexone in Opioid-Induced Constipation
Study Results Show Positive Effect of Oral Monthly Boniva in Management of Osteoporosis
Efforts To Seek U.S. Approval for Agalsidase Halted
Study Shows Dalbavancin Superior to Vancomycin For Gram-Positive Catheter-Related Bloodstream Infections
Provenge Extends Survival in Advanced Prostate Cancer by Eight Months
Interim Results of GTI-2040 Trial in End-Stage Renal Cancer Show Disease Stabilization and Tumor Shrinkage
FDA Approves Oxaliplatin for the First Line Treatment of Metastatic Colorectal Cancer
Atiprimod Granted Orphan Drug Designation for Multiple Myeloma Indication
Tentative Approval for Generic Glucophage Withdrawn by FDA
Generic Lotrisone Cream Now Available
FDA Approves Pre-Filled Syringes of Pegasys
Second Phase II Study of Lidocaine Solution in Asthma Initiated
Phase II Trial Initiated of LymphoStat-B for the Treatment of Rheumatoid Arthritis
Ambrisentan Phase III Trial To Begin
Generic Topomax Tentatively Approved in 25-, 100-, and 200-mg Doses
New Dosing Regimen for Saquinavir Approved by FDA
Phase III Studies for Dapsone Completed
Blood Sugar Control Linked to Angioplasty or Stenting Success Rates
Mefloquine Hydrochloride Tablets Approved by FDA
Bortezomib Phase II Colorectal Trial Closed
Patients Participating in Ziconotide Phase III Trial Experience Significant Pain Reduction
Phase II Trial Initiated With Once-Daily Diuretic Furosemide
Phase III Study of Secretin for Autism Fails To Meet Primary Endpoints
Positive Results Reported From Phase II Trial of Isis 104838 in Rheumatoid Arthritis
Phase III Study of Motexafin Demonstrates Positive Neurocognitive Function Results

From the PharmD Corner

Up and Up They Go. Can Drug Prices Be Brought Down to Earth in 2019?

Dipal Patel, PharmD, RPh

Clinical Brief

Multiple Sclerosis: New Perspectives on the Patient Journey–2019 Update
Summary of an Actuarial Analysis and Report

Click to download

P&T Product Profiler

ZULRESSO™ (brexanolone) injection CIV

Click to download

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PTCommunity News January 2004