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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
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).
27 Sep 2019
Quadrivalent influenza vaccine (split virion, inactivated) 0.5 mL inj
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.
Stephen Padilla, 17 Dec 2019
The use of aspirin for primary prevention in patients without known cardiovascular diseases (CVDs) significantly reduces the risk of myocardial infarction (MI) but increases that of major bleeding and haemorrhagic stroke, according to a meta-analysis.