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, 4 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 - 30 September 2020)

01 Oct 2020
New drug applications approved by US FDA as of 16 - 30 September 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.

XELJANZ
  • Active Ingredient(s): Tofacitinib
  • Strength: 5 mg
  • Dosage Form(s) / Route(s): Solution; oral
  • Company: Pfizer, Inc.
  • Approval Date: 25 September 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for:
    • Rheumatoid Arthritis: XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
    • Psoriatic Arthritis: XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
    • Ulcerative Colitis: XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or who are intolerant to TNF blockers.
    • Polyarticular Course Juvenile Idiopathic Arthritis: XELJANZ/XELJANZ XR Oral Solution is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older.
  • Approved Label25 September 2020 (PDF)

ALKINDI SPRINKLE
  • Active Ingredient(s): Hydrocortisone
  • Strength: 0.5 mg; 1 mg; 2.5 mg; 5 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Diurnal Ltd.
  • Approval Date: 29 September 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated as replacement therapy in pediatric patients with adrenocortical insufficiency.
  • Approved Label29 September 2020 (PDF)

ATROPINE SULFATE
  • Active Ingredient(s): Atropine sulfate
  • Strength: 0.4 mg/mL; 1 mg/mL
  • Dosage Form(s) / Route(s): Solution; injection
  • Company: Accord Healthcare
  • Approval Date: 29 September 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for temporary blockade of severe or life threatening muscarine effects.
  • Approved Label29 September 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, 4 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.