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 (1 - 15 September 2018)

15 Sep 2018
New drug applications approved by US FDA as of 1 - 15 September 2018 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.

TIGLUTIK
  • Active Ingredient(s): Riluzole
  • Strength: 50MG/ML
  • Dosage Form(s)/Route(s): Suspension; Oral
  • Company: Italfarmaco SpA
  • Approval Date: 09 Sep 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of amyotrophic lateral sclerosis (ALS)
  • Approved Label: 09 Sep 2018 (PDF)
CASSIPA
  • Active Ingredient(s): Buprenorphine; Naloxone
  • Strength: 16MG; 4MG
  • Dosage Form(s)/Route(s): Film; Buccal, Sublingual
  • Company: Teva Pharms USA Inc
  • Approval Date: 07 Sep 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the maintenance treatment of opioid dependence
  • Approved Label: 07 Sep 2018 (PDF)
XELPROS
  • Active Ingredient(s): Lantanoprost
  • Strength: 0.005%
  • Dosage Form(s)/Route(s): Emulsion; Ophthalmic
  • Company: Sun Pharma Global
  • Approval Date: 12 Sep 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for reduction of elevated intraocular pressure in patients with open-angle glaucoma, or ocular hypertension
  • Approved Label: 12 Sep 2018 (PDF)
LUMOXITI
  • Active Ingredient(s): Moxetumomab pasudotox-tdfk
  • Strength: 1MG/VIAL
  • Dosage Form(s)/Route(s): Injectable; Injection
  • Company: AstraZeneca AB
  • Approval Date: 13 Sep 2018
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA)
  • Approved Label: 13 Sep 2018 (PDF)
SEIZALAM
  • Active Ingredient(s): Midazolam
  • Strength: 5MG/ML
  • Dosage Form(s)/Route(s): Injectable; Injection
  • Company: Meridian Medical Techn.
  • Approval Date: 14 Sep 2018
  • Submission Classification: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
  • Indication(s): Not available
  • Approved Label: Not available
AJOVY
  • Active Ingredient(s): Fremanezumab-VFRM
  • Strength: 150MG/ML
  • Dosage Form(s)/Route(s): Injectable; Injection
  • Company: Teva Pharms USA
  • Approval Date: 14 Sep 2018
  • Submission Classification: Not available
  • Indication(s): Indicated for the preventive treatment of migraine in adults
  • Approved Label: 14 Sep 2018 (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.