PRESCRIPTION MEDICINE NEWS

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These product press releases are intended for use in the United States only. Countries outside of the U.S. may have different regulatory requirements and review practices that may require referencing different information.


Jun. 10, 2011   Merck Statement Regarding FDA Approval of Changes to Trade Packaging Design for Several Medicines from Merck
     
Dulera® (mometasone furoate/formoterol fumarate dihydrate)
Medication Guide
Oct. 24, 2011   Merck Announces Presentation of Phase III Investigational Studies Evaluating DULERA® (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol in Chronic Obstructive Pulmonary Disease (COPD)
     
ISENTRESS® (raltegravir)
Patient Product Information
Jan. 06, 2012   FDA Approves Merck’s ISENTRESS® (raltegravir) for Use in Children Ages Two Years and Older as Part of HIV-1 Combination Therapy
Dec. 21, 2011   Merck and the ADAP Crisis Task Force Announce New Agreement to Improve Access and Care for People with HIV
Oct. 13, 2011   Merck's ISENTRESS® (raltegravir) in Combination Therapy Demonstrated Virological and Immunological Efficacy Versus the Efavirenz Regimen at 192 Weeks of Treatment in Previously Untreated Adults with HIV-1
Sept. 19, 2011   Merck's ISENTRESS® (raltegravir) in Combination Therapy Demonstrated Efficacy and Tolerability in an Observational Trial in a Diverse Population of Adults with HIV-1 Regardless of Gender or Race
July 18, 2011   Merck's ISENTRESS® (raltegravir) in Combination Therapy Demonstrated Efficacy in a Phase II Study Extending to Nearly Five Years in Previously Untreated Adults with HIV-1
Mar 01, 2011   Merck's ISENTRESS® (raltegravir) Demonstrated Durable Reductions in HIV-1 Viral Load and Sustained Tolerability At Three Years of Treatment in Previously Untreated Adult Patients Infected with HIV-1
     
JANUMET® (sitagliptin/metformin HCl) tablets
Medication Guide
Jun. 25, 2011   In a New Post-Hoc Analysis Based on the AACE/ACE Diabetes Algorithm Significantly More Patients Achieved Blood Sugar Goals with Initial Therapy with Merck's Diabetes Medicine JANUMET® (sitagliptin/metformin HCl) Compared to Metformin Alone
     
JANUMET® XR (sitagliptin and metformin HCl extended-release) Tablets
Medication Guide
Feb. 02, 2012   FDA Approves JANUMET® XR (sitagliptin and metformin HCl extended-release) for Type 2 Diabetes, Offering the Powerful Efficacy of JANUMET® (sitagliptin/metformin HCl) Now Available with Once-Daily Convenience
     
JUVISYNC® (sitagliptin and simvastatin) Tablets
Medication Guide
Oct. 07, 2011   FDA Approves Merck's JUVISYNC (sitagliptin and simvastatin) Tablets, a Once-Daily Therapy for Patients with Type 2 Diabetes Who Need to Lower Blood Sugar and Cholesterol, Known Risk Factors for Cardiovascular Disease
     
NEXPLANON® (etonogestrel implant) Radiopaque Subdermal Use Only
Patient Product Information
Nov. 09, 2011   Merck Launches NEXPLANON® (etonogestrel implant) 68 mg in the United States - A Long-Acting Reversible Hormonal Contraceptive Effective For Up to Three Years
     
REMICADE® (infliximab)
Apr. 15, 2011   Merck and Johnson & Johnson Reach Agreement on Distribution Rights for REMICADE® and SIMPONI®
     
SYLATRON (peginterferon alfa-2b) for Injection
Apr. 11, 2011   FDA Approves Merck's SYLATRON (peginterferon alfa-2b) for Injection, a New Adjuvant Treatment for Melanoma with Microscopic or Gross Nodal Involvement
     
VICTRELIS (boceprevir)
Feb. 08, 2012   Merck Informs Physicians of Results of Drug Interaction Study of Co-Administration of VICTRELIS with Ritonavir-Boosted HIV Protease Inhibitors
Dec. 15, 2011   Merck Announces Initiation of Clinical Development Collaboration with Roche To Evaluate Investigational Combination Regimens for the Treatment of Chronic Hepatitis C Genotype 1 Infection
Nov. 5, 2011   Interim Data for Merck's VICTRELIS (boceprevir) in Prior Null Responder Patients with Chronic Hepatitis C Genotype 1 to be Presented at The American Association for the Study of Liver Diseases 2011 Annual Meeting
Oct. 20, 2011   Interim Phase IIb Data for Merck's VICTRELIS (boceprevir) in Patients Coinfected with Chronic Hepatitis C and HIV-1 Presented at the Infectious Diseases Society of America (IDSA) 2011 Annual Meeting
Sept. 30, 2011   Merck Announces New Data Analyses for VICTRELIS (boceprevir) will be Presented at The American Association for the Study of Liver Diseases 2011 Annual Meeting
July 18, 2011   VICTRELIS (boceprevir), First-in-Class Oral Hepatitis C Virus Protease Inhibitor, Approved in the European Union for Treatment of Chronic Hepatitis C
May 20, 2011   CHMP Issues Positive Opinion for Merck's VICTRELIS (boceprevir), Oral Hepatitis C Virus (HCV) Protease Inhibitor
May 13, 2011   FDA Approves Merck's VICTRELIS (boceprevir), First-in-Class Oral Hepatitis C Virus (HCV) Protease Inhibitor
     
VYTORIN® (ezetimibe/simvastatin)
Patient Product Information
Jan. 25, 2012   New FDA Approved Labeling For VYTORIN® (Ezetimibe/Simvastatin) Includes Results From the Study of Heart and Renal Protection (SHARP) in Patients With Moderate to Severe Chronic Kidney Disease
Nov. 2, 2011   FDA Advisory Committee Unanimously Recommends Approval of Merck's VYTORIN® (ezetimibe/simvastatin) for Use in Patients with Pre-Dialysis Chronic Kidney Disease
June 08, 2011   U.S. Prescribing Information for Simvastatin Revised to Include New Limits on the Use of the Highest Dose -- 80 mg -- and Updated Drug Interaction Information
     
ZOCOR® (simvastatin)
 
June 08, 2011   U.S. Prescribing Information for Simvastatin Revised to Include New Limits on the Use of the Highest Dose -- 80 mg -- and Updated Drug Interaction Information
     
ZOLINZA® vorinostat)
Dec. 12, 2011   Merck Announces Results of ZOLINZA® (vorinostat) Phase III and IIb Trials for Investigational Use for Multiple Myeloma at American Society of Hematology Annual Meeting
Sept. 23, 2011   Study of ZOLINZA® (vorinostat) for Investigational Use for Advanced Malignant Pleural Mesothelioma Did Not Meet Primary Endpoint
July 1, 2011   Merck Receives Approval to Market GARDASIL®, ZOLINZA® and CUBICIN® in Japan
     

 

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