Most Read Articles
Tristan Manalac, 16 May 2018
Although the conversion rate of ocular (OMG) to generalized (GMG) myasthenia gravis in Asian patients is low, thymoma and acetylcholine receptor (AchR) antibodies as well as positivity in repetitive nerve stimulation (RNS) studies all predict such generalization, a recent Singapore study has shown.

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
Tristan Manalac, 16 May 2018
Although the conversion rate of ocular (OMG) to generalized (GMG) myasthenia gravis in Asian patients is low, thymoma and acetylcholine receptor (AchR) antibodies as well as positivity in repetitive nerve stimulation (RNS) studies all predict such generalization, a recent Singapore study has shown.