Most Read Articles
Christina Lau, 14 Feb 2019
Progress in the treatment of rare cancers has been named Advance of the Year by the American Society of Clinical Oncology (ASCO).
Pearl Toh, 28 Aug 2019
The addition of radium-223 (Ra223) to enzalutamide for the treatment of mCRPC* was associated with increased fracture risk, which was entirely abolished with mandated use of bone-protecting agents (BPAs) such as zoledronic acid and denosumab, according to interim results of the EORTC 1333 (PEACE III) trial.
Audrey Abella, 28 Aug 2019
A pooled analysis of six trials failed to show noninferiority of a 3-month regimen to a 6-month regimen of oxaliplatin-based chemotherapy for patients with high-risk, stage II colorectal cancer (CRC).

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
Christina Lau, 14 Feb 2019
Progress in the treatment of rare cancers has been named Advance of the Year by the American Society of Clinical Oncology (ASCO).
Pearl Toh, 28 Aug 2019
The addition of radium-223 (Ra223) to enzalutamide for the treatment of mCRPC* was associated with increased fracture risk, which was entirely abolished with mandated use of bone-protecting agents (BPAs) such as zoledronic acid and denosumab, according to interim results of the EORTC 1333 (PEACE III) trial.
Audrey Abella, 28 Aug 2019
A pooled analysis of six trials failed to show noninferiority of a 3-month regimen to a 6-month regimen of oxaliplatin-based chemotherapy for patients with high-risk, stage II colorectal cancer (CRC).