FDA Pipeline preview, October 2009 (Eplivanserin, Pancrelipase, Trabectedin, Clofarabine, Fampridine-SR, Collagenase clostridium histolyticum, Oxycodone reformulated, Pegylated interferon alfa-2b, Mar

FDA Pipeline preview, October 2009 (Eplivanserin, Pancrelipase, Trabectedin, Clofarabine, Fampridine-SR, Collagenase clostridium histolyticum, Oxycodone reformulated, Pegylated interferon alfa-2b, Maraviroc, Armodafinil, Relaxin, Perifosine, Glycerol phenylbutyrate, Trabedersen)
Publish date: Nov 1, 2009
By:  Formulary journal staff
Source: Formulary

Complete response

  • Eplivanserin (Ciltyri, Sanofi-aventis) for the treatment of patients with chronic insomnia characterized by difficulties with sleep maintenance.
  • Pancrelipase (Pancrecarb, Digestive Care) for the treatment of exocrine pancreatic insufficiency.
  • Trabectedin (Yondelis, Centocor Ortho Biotech) for the treatment of relapsed ovarian cancer in women.
  • Clofarabine (Clolar, Genzyme) for the treatment of previously untreated older adult patients with acute myeloid leukemia.

Recommended for approval

  • Fampridine-SR (Acorda) for the improvement of walking ability in patients with MS.
  • Collagenase clostridium histolyticum (Xiaflex, Auxilium Pharmaceuticals) for the treatment of Dupuytren's contracture.
  • Oxycodone reformulated (OxyContin, Purdue Pharma) designed to be harder to abuse.
  • Pegylated interferon alfa-2b (Pegintron, Schering-Plough) for the adjuvant treatment of Stage III malignant melanoma.
  • Maraviroc (Selzentry, Pfizer) tablets for use in treatment-naïve adult patients with CCR5-tropic HIV-1 virus as part of combination therapy.

Priority review

  • Armodafinil (Nuvigil, Cephalon) for additional use of the treatment of excessive sleepiness tied to jet lag.

Fast-track designation
  • Relaxin (Corthera) for the treatment of acute heart failure.

Orphan-drug designation

  • Perifosine (KRX-0401, Keryx Biopharmaceuticals) for the treatment of multiple myeloma.
  • Glycerol phenylbutyrate (HPN-100, Hyperion Therapeutics) for the intermittent or chronic treatment of cirrhosis and any grade of hepatic encephalopathy.
  • Trabedersen (Antisense Pharma) for the treatment of pancreatic carcinoma.

post a comment
Please complete the form below to post your comment.
Bold = Required
Email Address Your email address will NOT be published.
Display Name appears with your comment
City
State
Country
Remember me: YesNo
Comment read our privacy policy
Note: does not support HTML
All comments submitted are subject to review, and may be delayed before posting. We reserve the right not to post comments.
eSamples check closet
eSamples check closet
Practice ToolsPractice Tools
Coding Counselor
Coding Counselor

Simple and accurate ICD-9 code search. Start Here

Patient Education
Patient Education

Print customized patient education handouts. Start Here

Surgical Video Center
Surgical Video Center

On-demand surgery demos and presentations. Start Here

Featured Jobs

More Jobs

Clinical Perspectives
AcneAdolescent MedicineAllergy & ImmunologyAlzheimer's DiseaseAsthmaBPHBreast CancerCardiologyCataractsChild Behavior & DevelopmentClinical PharmacologyContraceptionCorneal DiseaseCosmetic DermatologyCosmetic SurgeryDepressionDermatologyDiabetesDry EyeEczema/Atopic DermatitisEndocrinologyEpilepsyErectile DysfunctionGastroenterologyGastroesophageal Reflux Disease (GERD) & Acid Peptic DiseaseGeriatricsGlaucomaGynecologic OncologyHIV/AIDSHormone TherapyHyperlipidemiaHypertensionImmunization/VaccinesInfectious Disease Internal MedicineIrritable Bowel Syndrome (IBS)Kidney & Bladder CancerLaser & Light Technology in DermatologyMaternal & Fetal MedicineMenopauseMigraineMultiple SclerosisNeurologyNutritionOb/Gyn SurgeryObesityOB/GYN & Women's HealthOncologyOphthalmologyOptometryOrthopedicsOsteoporosisParkinson's DiseasePathologyPediatricsPrimary Care MedicineProstate CancerPsoriasisPsychiatry & Behavioral HealthRadiologyRefractive SurgeryReproductive Endocrinology/InfertilityRetinal DiseaseRheumatoid ArthritisSkin CancerSleep DisordersSmoking-Related IllnessStrokeSurgeryUrinary Incontinence/Overactive BladderUrologic SurgeryUrology
Business Perspectives
Coding CounselorLiability & Risk ManagementHealth Care Information TechnologyPractice ManagementBusiness OperationsHuman ResourcesHealth Law & PolicyManaged CarePersonal FinanceProducts
Popular Topics
CME/CECoding CounseloreNewslettersPatient Education CenterBlogsDiscussionsModernMedicine RadioSyndicationSurgical Video Center


Source: Formulary, 11/1/2009
Click here