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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
Roshini Claire Anthony, 09 Oct 2020

The risk of falls and subsequent injuries (eg, fractures) may be elevated in individuals with diabetes compared with the general population, according to a nationwide cohort study from Denmark.

Audrey Abella, 10 Sep 2020
Interim results of REGENERATE* trial highlight the ability of experimental noninvasive tests to evaluate treatment response in adults with NASH** and advanced liver fibrosis who are receiving obeticholic acid (OCA).
Rachel Soon, 28 Aug 2020
MOH Director-General Tan Sri Dato' Seri Dr Noor Hisham Abdullah speaks about NHMS 2019 and pharmacists' roles in combating NCDs among Malaysians.
Jairia Dela Cruz, 23 Sep 2020
The combination of pitavastatin and fenofibrate appears to have superior effect on non-high-density lipoprotein cholesterol (non–HDL-C), as well as other lipids, compared with a statin alone in high-risk patients with mixed dyslipidemia, according to a study.