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Reports

We found 4959 result(s)

migalastat (Galafold)

Last Updated: January 26, 2018
Result type: Reports
Product Line: Common Drug Review
Generic Name: migalastat
Indications: Fabry Disease

  • Brand Name: Galafold
  • Manufacturer: Amicus Therapeutics
  • Project Number: SR0522-000
  • Project Status: Active
  • Submission Type: New

Tags

Genetics, Nervous System, Fabry Disease, Genetics, Nervous system, migalastat

cysteamine bitartrate (Procysbi)

Last Updated: January 26, 2018
Result type: Reports
Product Line: Common Drug Review
Generic Name: cysteamine bitartrate
Indications: Nephropathic cystinosis

  • Brand Name: Procysbi
  • Manufacturer: Horizon Pharma
  • Project Number: SR0526-000
  • Project Status: Active
  • Submission Type: New

Tags

Genetics, Pediatrics, Cysteamine, Cystinosis, Delayed-Action Preparations, Genetics, Pediatrics, Procysbi; cysteamine bitartrate; cystinosis; delayed release; sustained release; extended release; nephropathic; delayed action; controlled release; time release

ozenoxacin (Ozanex)

Last Updated: January 26, 2018
Result type: Reports
Product Line: Common Drug Review
Generic Name: ozenoxacin
Indications: Impetigo

  • Brand Name: Ozanex
  • Manufacturer: Cipher Pharmaceuticals Inc.
  • Project Number: SR0553-000
  • Project Status: Received
  • Submission Type: New

Tags

Dermatology, Pediatrics, Dermatology, Pediatrics

nitisinone (Nitisinone )

Last Updated: January 26, 2018
Result type: Reports
Product Line: Common Drug Review
Generic Name: nitisinone
Indications: Hereditary tyrosinemia type 1

  • Brand Name: Nitisinone
  • Manufacturer: Cycle Pharmaceuticals Ltd.
  • Project Number: SR0554-000
  • Project Status: Received
  • Submission Type: New

Tags

Genetics, Pediatrics, Genetics, Pediatrics

nitisinone (MDK-Nitisinone)

Last Updated: January 25, 2018
Result type: Reports
Product Line: Common Drug Review
Generic Name: nitisinone
Indications: Hereditary tyrosinemia type 1

  • Brand Name: MDK-Nitisinone
  • Manufacturer: MendeliKABS Inc
  • Project Number: SR0538-000
  • Project Status: Active

Tags

Digestive System, Genetics, Pediatrics, Tyrosinemias, Digestive system, Genetics, Pediatrics, nitisinone; tyrosinemia

sofosbuvir velpatasvir voxilaprevir (Vosevi )

Last Updated: January 26, 2018
Result type: Reports
Product Line: Common Drug Review
Generic Name: sofosbuvir velpatasvir voxilaprevir
Indications: Hepatitis C, chronic

  • Brand Name: Vosevi
  • Manufacturer: Gilead Sciences Canada, Inc.
  • Project Number: SR0529-000
  • Project Status: Active
  • Submission Type: NewCombination

Tags

Hepatitis, Hepatitis C, Hepatitis, sofosbuvir; velpatasvir; voxilaprevir

ocrelizumab (Ocrevus)

Last Updated: January 25, 2018
Result type: Reports
Product Line: Common Drug Review
Generic Name: ocrelizumab
Indications: multiple sclerosis, relapsing

  • Brand Name: Ocrevus
  • Manufacturer: Hoffman-La Roche Limited
  • Project Number: SR0519-000
  • Project Status: Complete
  • Submission Type: New

Tags

Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting, Multiple sclerosis, Multiple Sclerosis; Multiple sclerosis treatment

glecaprevir pibrentasvir (Maviret)

Last Updated: January 25, 2018
Result type: Reports
Product Line: Common Drug Review
Generic Name: glecaprevir pibrentasvir
Indications: Hepatitis C, chronic

  • Brand Name: Maviret
  • Manufacturer: AbbVie Corporation
  • Project Number: SR0523-000
  • Project Status: Active
  • Submission Type: New

Tags

Hepatitis, Hepatitis C, Chronic, Hepatitis, maviret; glecaprevir/pibrentasvir; mavyret