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30 Oct 2017
Children with autism spectrum disorders (ASD) appear to have significantly altered gut mucosal mitochondrial function compared with controls and other children with nonspecific gastrointestinal symptoms, a recent study shows.
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15 Aug 2017
New drug applications approved by US FDA as of 1 - 15 August 2017 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
01 Aug 2015
Genetic mutations in acute and recurrent acute pancreatitis elevates risk of chronic pancreatitis development based on single-centre study.

Original New Drug Application Approvals by US FDA (1 - 15 November 2017)

5 days ago
New drug applications approved by US FDA as of 1 - 15 November 2017 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%
  • Active Ingredient(s): Latanoprostene bunod
  • Strength: 0.024
  • Dosage Form: Ophthalmic solution
  • Company: Bausch and Lomb Inc
  • Approval Date: November 02, 2017
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension
  • Approved Label: 11/02/2017 (PDF)

BORTEZOMIB
  • Active Ingredient(s): Bortezomib
  • Strength: 3.5 mg
  • Dosage Form: Injectable;injection
  • Company: Fresenius Kabi USA
  • Approval Date: November 06, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for
    • treatment of patients with multiple myeloma
    • treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy
  • Approved Label: 11/06/2017 (PDF)

PREVYMIS
  • Active Ingredient(s): Letermovir
  • Strength: 240 mg, 480 mg
  • Dosage Form: Tablet;oral
  • Company: Merck Sharp Dohme
  • Approval Date: November 08, 2017
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT)
  • Approved Label: 11/08/2017 (PDF)

PREVYMIS
  • Active Ingredient(s): Letermovir
  • Strength: 240 mg/12ml, 480 mg/24ml
  • Dosage Form: Injectable;injection
  • Company: Merck Sharp Dohme
  • Approval Date: November 08, 2017
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT)
  • Approved Label: 11/08/2017 (PDF)

CINVANTI (aprepitant) injectable emulsion
  • Active Ingredient(s): Aprepitant
  • Strength: 130mg
  • Dosage Form: Injectable;injection
  • Company:  Heron Theraps Inc
  • Approval Date: November 09, 2017
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated in adults, in combination with other antiemetic agents, for the prevention of:
    • acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin
    • nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)
  • Approved Label: 11/09/2017 (PDF) 
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Most Read Articles
30 Oct 2017
Children with autism spectrum disorders (ASD) appear to have significantly altered gut mucosal mitochondrial function compared with controls and other children with nonspecific gastrointestinal symptoms, a recent study shows.
29 Aug 2015
Non-operative management of acute pancreatitis substantially decreased exocrine and endocrine dysfunction compared with operative method, a recent study shows.
15 Aug 2017
New drug applications approved by US FDA as of 1 - 15 August 2017 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
01 Aug 2015
Genetic mutations in acute and recurrent acute pancreatitis elevates risk of chronic pancreatitis development based on single-centre study.