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Original New Drug Application Approvals by US FDA (01 - 15 April 2019)

16 Apr 2019
New drug applications approved by US FDA as of 01 - 15 April 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.

WELCHOL
  • Active Ingredient(s): Colesevelam hydrochloride
  • Strength: 3.75 g
  • Dosage Form(s) / Route(s): Bar, chewable; Oral
  • Company: Daiichi Sankyo Inc.
  • Approval Date: 03 Apr 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated as an adjunct to diet and exercise to: 
    • reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia
    • reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH)
    • improve glycemic control in adults with type 2 diabetes mellitus
  • Approved Label: 03 Apr 2019 (PDF)

DOLUTEGRAVIR; LAMIVUDINE
  • Active Ingredient(s): Dolutegravir and lamivudine
  • Strength: 50 mg; 300 mg
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: ViiV Healthcare
  • Approval Date: 08 Apr 2019
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known substitutions associated with resistance to the individual components of DOVATO
  • Approved Label08 Apr 2019 (PDF)

EVENITY
  • Active Ingredient(s): Romosozumab-aqqg
  • Strength: 105 mg/1.17 mL
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Amgen Inc.
  • Approval Date: 09 Apr 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy
  • Approved Label09 Apr 2019 (PDF)

LEVOTHYROXINE SODIUM
  • Active Ingredient(s): Levothyroxine sodium
  • Strength: 100 mcg; 200 mcg; 500 mcg
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Fresenius Kabi USA
  • Approval Date: 11 Apr 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated in adult patients for the treatment of myxedema coma
  • Approved Label11 Apr 2019 (PDF)

BALVERSA
  • Active Ingredient(s): Erdafitinib
  • Strength: 3 mg; 4 mg; 5 mg
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Janssen Biotech
  • Approval Date: 12 Apr 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma that has:
    • susceptible FGFR3 or FGFR2 genetic alterations and
    • progressed during or following at least one line of prior platinum-containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
  • Approved Label11 Apr 2019 (PDF)
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