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

03 Mar 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 Label20 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 Label21 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 Label21 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 Label26 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 Label26 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 Label27 February 2020 (PDF)
Editor's Recommendations
Most Read Articles
6 days ago
Ivermectin confers benefits in the treatment of COVID-19, with a recent study showing that its use helps reduce the risk of death especially in patients with severe pulmonary involvement.
5 days ago
Mental health comorbidities are common among patients with type 2 diabetes mellitus and may lead to worse outcomes, a recent study has found.
Roshini Claire Anthony, 13 Nov 2020

Diabetes is a key risk factor for heart failure (HF), which is the leading cause of hospitalization in patients with or without diabetes. SGLT-2* inhibitors (SGLT-2is) have been shown to reduce the risk of hospitalization for HF (HHF) regardless of the presence or absence of diabetes.

2 days ago
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