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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)
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Most Read Articles
Elvira Manzano, 3 days ago
Bisphosphonates have proven antifracture efficacy and remain to be the cornerstone of osteoporosis treatment. However, a drug holiday is of particular importance with bisphosphonates due to some signals with long-term use of the drug, including rare incidence of atypical femoral fracture (AFF) and osteonecrosis of the jaw (ONJ), says a leading endocrinologist at AFOS 2017.
Pearl Toh, 13 Oct 2017
Women with higher plasma tryptophan concentrations were less likely to have poor sleep quality during pregnancy, especially among those with anxiety symptoms, according to the GUSTO* study.
5 days ago
Second eye cataract surgery provides greater improvement in visual function and quality of life compared with first eye cataract surgery alone, a recent study claims.
4 days ago
The size and shape of a person’s face may predict sex drive and intended infidelity, research has shown.