Most Read Articles
Stephen Padilla, 12 Dec 2019
Transitioning from bortezomib- to ixazomib-based induction is feasible, tolerable and effective in the treatment of community patients with newly diagnosed multiple myeloma (NDMM), according to a study presented at the 61st Annual Meeting of the American Society of Hematology (ASH 2019).
10 Mar 2017
The addition of pravastatin to standard chemotherapy does not improve outcomes in patients with small-cell lung cancer (SCLC), results of a study have shown.
Tristan Manalac, 03 Dec 2019
Incorporating basic tumour characteristics, such as hormone receptor status and tumour origin, improves the power of the cell-loss metric to predict response to treatment, according to a new study presented at the recently concluded 2019 Asia Congress of the European Society for Medical Oncology (ESMO Asia 2019).
Audrey Abella, 2 days ago
A moderately hypofractionated radiotherapy (RT) dose schedule was noninferior to conventional RT, according to the 8-year outcomes from the CHHiP* trial presented at ASCO GU 2020.

Original New Drug Application Approvals by US FDA (1 -15 June 2018)

15 Jun 2018

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

    FULPHILA

  • Active Ingredient(s): Pegfilgrastim-JMDB
  • Strength: 6 mg/0.6 ml
  • Dosage Form: Injectable;injection
  • Company: Mylan GMBH
  • Approval Date: June 04, 2018
  • Submission Classification: Not applicable
  • Indication(s): Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
  • Approved Label: 06/04/2018(PDF)

  MOXIDECTIN
  • Active Ingredient(s): Moxidectin
  • Strength: 2 mg
  • Dosage Form: Tablet;oral
  • Company: Medicines Development for Global Health
  • Approval Date:  June 13, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older.
  • Approved Label: 06/13/2018(PDF)
LYMEPAK
  • Active Ingredient(s): Doxycycline Hyclate
  • Strength: 100 mg
  • Dosage Form: Tablet;oral
  • Company: Chartwell Pharma
  • Approval Date: June 15, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for  the treatment of early Lyme disease (as evidenced by erythema migrans) due to Borrelia burgdorferi in adults and pediatric patients 8 years of age and older weighing 45 kg and above.
  • Approved Label: 06/15/2018(PDF)
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Editor's Recommendations
Most Read Articles
Stephen Padilla, 12 Dec 2019
Transitioning from bortezomib- to ixazomib-based induction is feasible, tolerable and effective in the treatment of community patients with newly diagnosed multiple myeloma (NDMM), according to a study presented at the 61st Annual Meeting of the American Society of Hematology (ASH 2019).
10 Mar 2017
The addition of pravastatin to standard chemotherapy does not improve outcomes in patients with small-cell lung cancer (SCLC), results of a study have shown.
Tristan Manalac, 03 Dec 2019
Incorporating basic tumour characteristics, such as hormone receptor status and tumour origin, improves the power of the cell-loss metric to predict response to treatment, according to a new study presented at the recently concluded 2019 Asia Congress of the European Society for Medical Oncology (ESMO Asia 2019).
Audrey Abella, 2 days ago
A moderately hypofractionated radiotherapy (RT) dose schedule was noninferior to conventional RT, according to the 8-year outcomes from the CHHiP* trial presented at ASCO GU 2020.