Most Read Articles
4 days ago
Children with high dental anxiety are more likely to develop dental diseases, which, in turn, negatively affect the family’s quality of life, a recent study has found.
3 days ago
Exposure to corticosteroids in patients with autoimmune hepatitis (AIH) appears to contribute to increased risks of cataract, diabetes and bone fractures, a study has found. Notably, the fracture risk is elevated at low doses, while the risk of adverse events overall is dose-dependent and is reversible.
4 days ago
Supplementation with oral nano vitamin D appears to moderate disease activity and severity grade of patients with active ulcerative colitis (UC), suggests a study, adding that this association is more evident in those achieving a target vitamin D level of 40 ng/mL.
Elvira Manzano, 12 Nov 2019
Supplementation with omega-3 fatty acids or vitamin D3 for up to 5 years has no effect on kidney function in adults with type 2 diabetes (T2D), the VITAL-DKD* ancillary study has shown.

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

15 Nov 2017
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) 

ABILIFY MYCITE
  • Active Ingredient(s): Aripiprazole
  • Strength: 2 mg |  5 mg | 10 mg | 15 mg | 20 mg | 30mg
  • Dosage Form: Oral with sensor tablet
  • Company: Otsuka Pharm Co Ltd
  • Approval Date: November 13, 2017
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated for
    • Treatment of adults with schizophrenia
    • Treatment of bipolar I disorder
      • Acute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate
      • Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate
    • Adjunctive treatment of adults with major depressive disorder (MDD)
  • Approved Label: 11/13/2017 (PDF)

TEKTURNA
  • Active Ingredient(s): Aliskiren
  • Strength: 37.5 mg
  • Dosage Form: Oral pellets
  • Company: Noden Pharma
  • Approval Date: November 14, 2017
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of hypertension in adults and children 6 years of age and older, to lower blood pressure
  • Approved Label: 11/14/2017 (PDF)

FASENRA
  • Active Ingredient(s): Benralizumab
  • Strength: 30 mg/mL
  • Dosage Form: Injectable;injection
  • Company: Astrazeneca AB
  • Approval Date: November 14, 2017
  • Submission Classification: Not available
  • Indication(s): Indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype
  • Approved Label: 11/14/2017 (PDF)

MEPSEVII
  • Active Ingredient(s): Vestronidase alfa-VJBK
  • Strength: 10 mg / 5 ml
  • Dosage Form: Injectable;injection
  • Company: Ultragenyx Pharm Inc
  • Approval Date: November 15, 2017
  • Submission Classification: Not available
  • Indication(s): Indicated for pediatric and adult patients for the treatment of Mucopolysaccharidosis type VII (MPS VII, Sly syndrome)
  • Approved Label: Not available
Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS JPOG - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
4 days ago
Children with high dental anxiety are more likely to develop dental diseases, which, in turn, negatively affect the family’s quality of life, a recent study has found.
3 days ago
Exposure to corticosteroids in patients with autoimmune hepatitis (AIH) appears to contribute to increased risks of cataract, diabetes and bone fractures, a study has found. Notably, the fracture risk is elevated at low doses, while the risk of adverse events overall is dose-dependent and is reversible.
4 days ago
Supplementation with oral nano vitamin D appears to moderate disease activity and severity grade of patients with active ulcerative colitis (UC), suggests a study, adding that this association is more evident in those achieving a target vitamin D level of 40 ng/mL.
Elvira Manzano, 12 Nov 2019
Supplementation with omega-3 fatty acids or vitamin D3 for up to 5 years has no effect on kidney function in adults with type 2 diabetes (T2D), the VITAL-DKD* ancillary study has shown.