Most Read Articles
Roshini Claire Anthony, 5 days ago

Patients with mild hypertension who are at low risk for cardiovascular disease (CVD) do not appear to derive mortality or CVD benefit from antihypertensive treatments, raising questions on the need for treatment in this population, according to a recent study from England.

Pearl Toh, 09 Nov 2018
A personalized computerized neurofeedback intervention for training attention and memory shows potential in cognitive training for healthy elderly men, who improved in cognitive performance after the training, although no significant improvements were seen in the overall study population.
3 days ago
Type 1 diabetes impairs cognitive functioning in children, and this effect is exacerbated by extreme glycaemic levels, according to a recent meta-analysis.
Pearl Toh, 08 Nov 2018
The pneumonia-causing bacteria, Streptococcus pneumoniae (pneumococcus), can be spread through nose picking and rubbing after exposure of the hands to the bacteria — in addition to the conventionally known route of inhalation of airborne droplets, a study reveals.

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
Roshini Claire Anthony, 5 days ago

Patients with mild hypertension who are at low risk for cardiovascular disease (CVD) do not appear to derive mortality or CVD benefit from antihypertensive treatments, raising questions on the need for treatment in this population, according to a recent study from England.

Pearl Toh, 09 Nov 2018
A personalized computerized neurofeedback intervention for training attention and memory shows potential in cognitive training for healthy elderly men, who improved in cognitive performance after the training, although no significant improvements were seen in the overall study population.
3 days ago
Type 1 diabetes impairs cognitive functioning in children, and this effect is exacerbated by extreme glycaemic levels, according to a recent meta-analysis.
Pearl Toh, 08 Nov 2018
The pneumonia-causing bacteria, Streptococcus pneumoniae (pneumococcus), can be spread through nose picking and rubbing after exposure of the hands to the bacteria — in addition to the conventionally known route of inhalation of airborne droplets, a study reveals.