Most Read Articles
23 Apr 2018
Long‐term treatment with perampanel in the adjunctive setting appears to provide improved seizure control without raising new safety/tolerability signals in patients with epilepsy, particularly those with secondarily generalized seizures at baseline, according to the results of an open-label extension of phase III trials.
Audrey Abella, 20 Mar 2020
The addition of highly purified cannabidiol (CBD) into an antiepileptic regimen led to reductions in convulsive seizure rates in children with Dravet syndrome (DS), the GWPCARE2* study has shown.
27 May 2020
High rather than low levels of neonatal 25(OH)D3 pose an increased risk of incident epilepsy in early childhood, a finding that may be attributed to chance, confounding, or late gestational vitamin D exposure, according to a study.
Jairia Dela Cruz, 29 Jan 2020
In the treatment of idiopathic generalized epilepsy, switching from valproate to other antiepileptic drugs due to potential childbearing issues may prove detrimental, heightening the risk of poor seizure control, as shown in a recent study.

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
23 Apr 2018
Long‐term treatment with perampanel in the adjunctive setting appears to provide improved seizure control without raising new safety/tolerability signals in patients with epilepsy, particularly those with secondarily generalized seizures at baseline, according to the results of an open-label extension of phase III trials.
Audrey Abella, 20 Mar 2020
The addition of highly purified cannabidiol (CBD) into an antiepileptic regimen led to reductions in convulsive seizure rates in children with Dravet syndrome (DS), the GWPCARE2* study has shown.
27 May 2020
High rather than low levels of neonatal 25(OH)D3 pose an increased risk of incident epilepsy in early childhood, a finding that may be attributed to chance, confounding, or late gestational vitamin D exposure, according to a study.
Jairia Dela Cruz, 29 Jan 2020
In the treatment of idiopathic generalized epilepsy, switching from valproate to other antiepileptic drugs due to potential childbearing issues may prove detrimental, heightening the risk of poor seizure control, as shown in a recent study.