Original New Drug Application Approvals by US FDA (16 - 29 February 2020)

03 Mar 2020
Original New Drug Application Approvals by US FDA (16 - 29 February 2020)
New drug applications approved by US FDA as of 16 - 29 February 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.

ANJESO
  • Active Ingredient(s): Meloxicam
  • Strength: 30 mg/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Baudax Bio, Inc.
  • Approval Date: 20 February 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for use in adults for management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.
  • Approved Label: 20 February 2020 (PDF)

NEXLETOL
  • Active Ingredient(s): Bempedoic acid
  • Strength: 180 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Esperion Therapeutics, Inc.
  • Approval Date: 21 February 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
  • Approved Label: 21 February 2020 (PDF)

VYEPTI
  • Active Ingredient(s): Eptinezumab-jjmr
  • Strength: 100 mg/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Lundbeck Seattle BioPharmaceuticals, Inc.
  • Approval Date: 21 February 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for the preventive treatment of migraine in adults.
  • Approved Label: 21 February 2020 (PDF)

BARHEMSYS
  • Active Ingredient(s): Amisulpride
  • Strength: 5 mg/2 mL (2.5 mg/mL)
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Acacia Pharma, Ltd.
  • Approval Date: 26 February 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in adults for:
    • Prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class.
    • Treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class of have not received prophylaxis.
  • Approved Label: 26 February 2020 (PDF)

NEXLIZET
  • Active Ingredient(s): Bempedoic acid; ezetimibe
  • Strength: 180 mg/10 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Esperion Therapeutics, Inc.
  • Approval Date: 26 February 2020
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular diseae who require additional lowering of LDL-C.
  • Approved Label: 26 February 2020 (PDF)

NURTEC ODT
  • Active Ingredient(s): Rimegepant
  • Strength: 75 mg
  • Dosage Form(s) / Route(s): Tablet, orally disintegrating; oral
  • Company: Biohaven Pharma Holding Co., Ltd.
  • Approval Date: 27 February 2020 
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the acute treatment of migraine with or without aura in adults.
  • Approved Label: 27 February 2020 (PDF)