Most Read Articles
04 Oct 2020
Obesity does not appear to be strongly correlated with an increased risk for febrile neutropaenia during levofloxacin prophylaxis in patients with haematological malignancies receiving intermediate-risk myelosuppressive chemotherapy, suggests a study.
Roshini Claire Anthony, 5 days ago

Initiation or switch to the single-tablet regimen of bictegravir/emtricitabine/tenofovir alafenamide (TAF) led to low HIV-1 RNA viral load in people living with HIV (PLHIV), according to the BICSTaR study presented at HIV Glasgow 2020.

09 Nov 2020
Use of corticosteroids appears to be an effective treatment for paediatric drug reaction with eosinophilia and systemic symptoms (DRESS), suggest the results of a recent study. In severe cases, corticosteroids used in conjunction with intravenous immunoglobulin result in fast clinical improvement.
Stephen Padilla, 10 Nov 2020
Patients with chronic obstructive pulmonary disease (COPD) seem to benefit from using chlorhexidine oral rinses twice daily as shown by the reduction in oral and sputum microbiota alpha diversity and by clinically significant improvements in COPD symptoms, according to a study presented at ID Week 2020.

Original New Drug Application Approvals by US FDA (16 - 31 January 2020)

31 Jan 2020
New drug applications approved by US FDA as of 16 - 31 January 2020 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.

MONOFERRIC
  • Active Ingredient(s): Ferric derisomaltose
  • Strength: 100 mg/mL; 500 mg/5 mL; 1,000 mg/10 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Pharmacosmos As
  • Approval Date: 16 January 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of iron deficiency anemia in adult patients:
    • who have intolerance to oral iron or have had unsatisfactory response to oral iron.
    • who have non-hemodialysis dependent chronic kidney disease.
  • Approved Label16 January 2020 (PDF)

RYBELSUS
  • Active Ingredient(s): Semaglutide
  • Strength: 3 mg; 7 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Novo Nordisk, Inc.
  • Approval Date: 16 January 2020
  • Submission Classification:Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval
  • Indication(s): Indicated as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Approved Label16 January 2020 (PDF)

TEPEZZA
  • Active Ingredient(s): Teprotumumab-trbw
  • Strength: 500 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Horizon Therapeutics Ireland
  • Approval Date: 21 January 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of Thyroid Eye Disease.
  • Approved Label21 January 2020 (PDF)

TAZVERIK
  • Active Ingredient(s): Tazemetostat
  • Strength: 200 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Epizyme, Inc.
  • Approval Date: 23 January 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
  • Approved Label23 January 2020 (PDF)

TRIJARDY XR
  • Active Ingredient(s): Empagliflozin; linagliptin; metformin hydrochloride
  • Strength: 25 mg; 5 mg; 2,000 mg
  • Dosage Form(s) / Route(s): Tablet, extended release; oral
  • Company: Boehringer Ingelheim
  • Approval Date: 27 January 2020
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Approved Label27 January 2020 (PDF)

BYNFEZIA PEN
  • Active Ingredient(s): Octreotide acetate
  • Strength: 100 mcg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Sun Pharm Inds, Ltd. 
  • Approval Date: 28 January 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for:
    • Reduction of growth hormone (GH) and insulin-like growth factor 1 (IGF-1) [somatomedin C] in adult patients with acromegaly who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses.
    • Treatment of severe diarrhea/flushing episodes associated with metastatic carcinoid tumors in adult patients.
    • Treatment of profuse watery diarrhea associated with vasoactive intestinal peptide tumors (VIPomas) in adult patients.
  • Approved Label28 January 2020 (PDF)
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Most Read Articles
04 Oct 2020
Obesity does not appear to be strongly correlated with an increased risk for febrile neutropaenia during levofloxacin prophylaxis in patients with haematological malignancies receiving intermediate-risk myelosuppressive chemotherapy, suggests a study.
Roshini Claire Anthony, 5 days ago

Initiation or switch to the single-tablet regimen of bictegravir/emtricitabine/tenofovir alafenamide (TAF) led to low HIV-1 RNA viral load in people living with HIV (PLHIV), according to the BICSTaR study presented at HIV Glasgow 2020.

09 Nov 2020
Use of corticosteroids appears to be an effective treatment for paediatric drug reaction with eosinophilia and systemic symptoms (DRESS), suggest the results of a recent study. In severe cases, corticosteroids used in conjunction with intravenous immunoglobulin result in fast clinical improvement.
Stephen Padilla, 10 Nov 2020
Patients with chronic obstructive pulmonary disease (COPD) seem to benefit from using chlorhexidine oral rinses twice daily as shown by the reduction in oral and sputum microbiota alpha diversity and by clinically significant improvements in COPD symptoms, according to a study presented at ID Week 2020.