Most Read Articles
01 Jan 2015
Ginkgo biloba has been shown to improve cognitive as well as neuropsychiatric symptoms (NPS) in patients with Alzheimer’s disease (AD) and mixed dementia. During a Schwabe-sponsored symposium last 20 October 2014 held at the University of Malaya in Malaysia, Professor Serge Gauthier of the McGill Centre for Studies in Aging in Quebec, Canada, and Dr Robert Hoerr of the Dr Willmar Schwabe GmbH & Co. KG in Germany, discussed studies that support the safety and efficacy of Ginkgo biloba extract (EGb 761®) in patients with AD and dementia.
26 Aug 2017
Elderly individuals with high levels of serum uric acid may be at an increased risk of dementia, particularly vascular or mixed dementia, a study suggests.
Dr. Joseph Delano Fule Robles, 01 Mar 2017

The tau and Aβ amyloid pathways have emerged as possible novel targets in treating Alzheimer’s disease (AD), according to studies discussed at the recently concluded Hong Kong Pharmacy Conference.

Original New Drug Application Approvals by US FDA (1 - 15 June 2017)

01 Aug 2017
New drug applications approved by US FDA as of 1 - 15 June 2017 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.

GLEOLAN
  • Active Ingredient(s): AMINOLEVULINIC ACID HYDROCHLORIDE
  • Strength: 1.5GM/VIAL
  • Dosage Form: Oral for solution
  • Company: NXDC
  • Approval Date: June 6, 2017
  • Chemical Type: Type 3 - New Dosage Form
  • Indication(s): Indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery
  • Approved Label: 06/06/2017 (PDF)

NORVIR
  • Active Ingredient(s): RITONAVIR
  • Strength: 100MG/PACKET
  • Dosage Form: Oral powder
  • Company: Abbvie Inc
  • Approval Date: June 7, 2017
  • Chemical Type: Type 3 - New Dosage Form
  • Indication(s): Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection
  • Approved Label: 06/07/2017 (PDF)

SYMJEPI
  • Active Ingredient(s): EPINEPHRINE
  • Strength: 0.3MG/ML (0.3MG/ML)
  • Dosage Form: Intramuscular, Subcutaneous Solution
  • Company: Adamis Pharms Corp
  • Approval Date: June 15, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis
  • Approved Label: 06/15/2017 (PDF)

CALCIUM GLUCONATE
  • Active Ingredient(s): CALCIUM GLUCONATE
  • Strength: 1GM/10ML (100MG/ML)
  • Dosage Form: IV (infusion) solution
  • Company: Fresenius Kabi USA
  • Approval Date: June 15, 2017
  • Chemical Type: Type 7 - Drug Already Marketed without Approved NDA
  • Indication(s): Indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia
  • Approved Label: 06/15/201 (PDF)
Editor's Recommendations
Most Read Articles
01 Jan 2015
Ginkgo biloba has been shown to improve cognitive as well as neuropsychiatric symptoms (NPS) in patients with Alzheimer’s disease (AD) and mixed dementia. During a Schwabe-sponsored symposium last 20 October 2014 held at the University of Malaya in Malaysia, Professor Serge Gauthier of the McGill Centre for Studies in Aging in Quebec, Canada, and Dr Robert Hoerr of the Dr Willmar Schwabe GmbH & Co. KG in Germany, discussed studies that support the safety and efficacy of Ginkgo biloba extract (EGb 761®) in patients with AD and dementia.
26 Aug 2017
Elderly individuals with high levels of serum uric acid may be at an increased risk of dementia, particularly vascular or mixed dementia, a study suggests.
Dr. Joseph Delano Fule Robles, 01 Mar 2017

The tau and Aβ amyloid pathways have emerged as possible novel targets in treating Alzheimer’s disease (AD), according to studies discussed at the recently concluded Hong Kong Pharmacy Conference.