Most Read Articles
22 Jan 2018
In a symposium chaired by Dr Yoon-Sim Yap of the National Cancer Centre Singapore, renowned regional and international experts in the field of breast cancer, Dr Yen-Shen Lu from Taiwan and Professor Nadia Harbeck from Germany, joined her in providing insights on the current treatment landscape of hormone receptor-positive (HR+) advanced breast cancer. In their respective sessions, they each highlighted new therapeutic options including the optimal use of dual blockade therapy for oestrogenreceptor-positive (ER+) advanced breast cancer for patients in Asia. 

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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Most Read Articles
22 Jan 2018
In a symposium chaired by Dr Yoon-Sim Yap of the National Cancer Centre Singapore, renowned regional and international experts in the field of breast cancer, Dr Yen-Shen Lu from Taiwan and Professor Nadia Harbeck from Germany, joined her in providing insights on the current treatment landscape of hormone receptor-positive (HR+) advanced breast cancer. In their respective sessions, they each highlighted new therapeutic options including the optimal use of dual blockade therapy for oestrogenreceptor-positive (ER+) advanced breast cancer for patients in Asia.