Most Read Articles
Audrey Abella, 20 Dec 2019
The combination of the immunomodulatory agent lenalidomide and the monoclonal antibody rituximab (R2) proved effective and safe in individuals ≥70 years with relapsed/refractory indolent non-Hodgkin lymphoma (R/R iNHL) compared with rituximab alone, according to a post hoc analysis of the phase III AUGMENT* trial presented at ASH 2019. 
26 Nov 2019
Podcast: Professor R. Scott Wright speaks about the potential role of inclisiran in providing durable reductions in LDL-cholesterol levels in patients with atherosclerotic cardiovascular disease.
Jairia Dela Cruz, 12 Dec 2019
Use of isatuximab (Isa) in combination with pomalidomide and dexamethasone (PomDex) appears to lead to more favourable outcomes in elderly patients with relapsed/refractory multiple myeloma (RRMM) as compared with PomDex alone, according to the results of a subgroup analysis of the ICARIA-MM trial presented at the 61st Annual Meeting of the American Society of Hematology (ASH 2019).
Elaine Soliven, 26 Dec 2019
Adding epoetin alfa (EA) to lenalidomide significantly helps achieve major erythroid response (MER) in patients with erythropoietin (Epo)-refractory, lower risk non-deletion 5q (non-del(5q)) myelodysplastic syndrome (MDS) compared with lenalidomide alone, according to the final results of the E2905* trial presented at ASH 2019.

Original New Drug Application Approvals by US FDA (16 - 30 September 2019)

01 Oct 2019
New drug applications approved by US FDA as of 16 - 30 September 2019 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.

OZOBAX
  • Active Ingredient(s): Baclofen
  • Strength: 5mg/mL
  • Dosage Form(s) / Route(s): Solution; oral
  • Company: Metacal Pharma, LLC
  • Approval Date: 18 September 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s):
    • Indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
    • May also be of some value in patients with spinal cord injuries and other spinal cord diseases.
  • Approved Label18 September 2019 (PDF)

POTASSIUM PHOSPHATES
  • Active Ingredient(s): Potassium phosphates
  • Strength: 3 mmol/mL; 4.7 mEq/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: CMP Development, LLC
  • Approval Date: 19 September 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated as a source of phosphorus:
    • in intravenous fluids to correct hypophosphatemia in adults and pediatric patients 12 years of age and older when oral or enteral replacement is not possible, insufficient or contraindicated.
    • for parenteral nutrition in adults weighing at least 45 kg and pediatric patients 12 years of age and older weighing at least 40 kg when oral or enteral nutrition is not possible, insufficient or contraindicated.
  • Approved Label19 September 2019 (PDF)

RYBELSUS
  • Active Ingredient(s): Semaglutide
  • Strength: 3 mg; 7 mg; 14 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Novo Nordisk, Inc.
  • Approval Date: 20 September 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Approved Label20 September 2019 (PDF)
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Most Read Articles
Audrey Abella, 20 Dec 2019
The combination of the immunomodulatory agent lenalidomide and the monoclonal antibody rituximab (R2) proved effective and safe in individuals ≥70 years with relapsed/refractory indolent non-Hodgkin lymphoma (R/R iNHL) compared with rituximab alone, according to a post hoc analysis of the phase III AUGMENT* trial presented at ASH 2019. 
26 Nov 2019
Podcast: Professor R. Scott Wright speaks about the potential role of inclisiran in providing durable reductions in LDL-cholesterol levels in patients with atherosclerotic cardiovascular disease.
Jairia Dela Cruz, 12 Dec 2019
Use of isatuximab (Isa) in combination with pomalidomide and dexamethasone (PomDex) appears to lead to more favourable outcomes in elderly patients with relapsed/refractory multiple myeloma (RRMM) as compared with PomDex alone, according to the results of a subgroup analysis of the ICARIA-MM trial presented at the 61st Annual Meeting of the American Society of Hematology (ASH 2019).
Elaine Soliven, 26 Dec 2019
Adding epoetin alfa (EA) to lenalidomide significantly helps achieve major erythroid response (MER) in patients with erythropoietin (Epo)-refractory, lower risk non-deletion 5q (non-del(5q)) myelodysplastic syndrome (MDS) compared with lenalidomide alone, according to the final results of the E2905* trial presented at ASH 2019.