Most Read Articles
Dr. Jay Zhu, Dr. Lai Fung Li, Prof. Chae-Yong Kim, 27 Nov 2019
The current standard of care for glioblastoma multiforme (GBM), an aggressive primary brain tumour with a rapid disease course, consists of maximum safe surgical resection followed by radiotherapy with concomitant temozolomide (TMZ) chemotherapy and subsequent TMZ maintenance. At the 16th Annual Meeting of the Asian Society of Neuro-Oncology (ASNO) in Taipei, Taiwan, experts reviewed the evidence and shared their clinical experience on the use of tumour treating fields (TTFields), a novel treatment modality for GBM. 

Original New Drug Application Approvals by US FDA (16 - 31 July 2018)

31 Jul 2018
New drug applications approved by US FDA as of 16 - 31 July 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.

INFUGEM
  • Active Ingredient(s): Gemcitabine 0.9%; Sodium chloride
  • Strength: 10mg/mL
  • Dosage Form: Injectable
  • Company: SUN PHARM INDS INC
  • Approval Date: 16 Jul 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s):
    Indicated in the following:
    • in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinumbased therapy
    • in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated
    • in combination with cisplatin for the treatment of non-small cell lung cancer
    • as a single agent for the treatment of pancreatic cancer
  • Approved Label: 16 Jul 2018 (PDF)
SYMTUZA
  • Active Ingredient(s): Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamid
  • Strength: 800mg; 150mg; 200mg; 10mg
  • Dosage Form: Tablet
  • Company: JANSSEN PRODS
  • Approval Date: 17 Jul 2018
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no prior antiretroviral treatment history or who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months and have no known substitutions associated with resistance to darunavir or tenofovir.
  • Approved Label: 17 Jul 2018 (PDF)
KRINTAFEL
  • Active Ingredient(s): Tafenoquine
  • Strength: 150mg
  • Dosage Form: Tablet
  • Company: GLAXOSMITHKLINE
  • Approval Date: 20 Jul 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection
  • Approved Label: 20 Jul 2018 (PDF)
TIBSOVO
  • Active Ingredient(s): Ivosidenib
  • Strength: 250mg
  • Dosage Form: Tablet
  • Company: AGIOS PHARMACEUTICALS INC
  • Approval Date: 20 Jul 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test
  • Approved Label: 20 Jul 2018 (PDF)
ORILISSA
  • Active Ingredient(s): Elagolix sodium
  • Strength: 150mg; 200mg
  • Dosage Form: Tablet
  • Company: ABBVIE INC
  • Approval Date: 23 Jul 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the management of moderate to severe pain associated with endometriosis
  • Approved Label: 23 Jul 2018 (PDF)
DOXERCALCIFEROL
  • Active Ingredient(s): Doxercalciferol
  • Strength: 4mcg/4mL; 10mcg/5mL
  • Dosage Form: Injectable; Injection
  • Company: HOSPIRA INC
  • Approval Date: 24 Jul 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis
  • Approved Label: 24 Jul 2018 (PDF)
OMEGAVEN
  • Active Ingredient(s): Fish oil triglycerides
  • Strength: 5g/50mL; 10g/100mL
  • Dosage Form: Emulsion; Intravenous
  • Company: FRESENIUS KABI USA
  • Approval Date: 27 Jul 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC)
  • Approved Label27 Jul 2018 (PDF)
AZEDRA
  • Active Ingredient(s): Iobenguane 131
  • Strength: 555mBq/mL (15mCi/mL)
  • Dosage Form: Injectable; Injection
  • Company: PROGENICS PHARMA INC
  • Approval Date: 30 Jul 2018
  • Submission Classification: Not Available
  • Indication(s): Indicated for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy
  • Approved Label30 Jul 2018 (PDF)
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Most Read Articles
Dr. Jay Zhu, Dr. Lai Fung Li, Prof. Chae-Yong Kim, 27 Nov 2019
The current standard of care for glioblastoma multiforme (GBM), an aggressive primary brain tumour with a rapid disease course, consists of maximum safe surgical resection followed by radiotherapy with concomitant temozolomide (TMZ) chemotherapy and subsequent TMZ maintenance. At the 16th Annual Meeting of the Asian Society of Neuro-Oncology (ASNO) in Taipei, Taiwan, experts reviewed the evidence and shared their clinical experience on the use of tumour treating fields (TTFields), a novel treatment modality for GBM.