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30 May 2019
Frailty shares a relationship with subjective cognitive decline in elderly women, which appears before the incidence of overt dementia, a recent study has found.
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Jackey Suen, 29 Nov 2018

Early detection, intervention and adoption of a healthy lifestyle are the key to ending dementia, according to Professor Vincent Mok of the Division of Neurology, Faculty of Medicine, Chinese University of Hong Kong.

Jairia Dela Cruz, 23 May 2019
Dimethyl fumarate appears to prevent relapse more effectively in relapsing-remitting multiple sclerosis (RRMS) compared with teriflunomide, as shown in the results of a real-world 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
30 May 2019
Frailty shares a relationship with subjective cognitive decline in elderly women, which appears before the incidence of overt dementia, a recent study has found.
05 Dec 2018
Traumatic brain injuries (TBI) appear to increase the risk of mortality among elderly adults with hip fractures, according to a recent study.
Jackey Suen, 29 Nov 2018

Early detection, intervention and adoption of a healthy lifestyle are the key to ending dementia, according to Professor Vincent Mok of the Division of Neurology, Faculty of Medicine, Chinese University of Hong Kong.

Jairia Dela Cruz, 23 May 2019
Dimethyl fumarate appears to prevent relapse more effectively in relapsing-remitting multiple sclerosis (RRMS) compared with teriflunomide, as shown in the results of a real-world study.