Most Read Articles
Naomi Rodrig, 15 Jun 2016
An interim analysis from the multinational phase III CASTOR trial, presented recently at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, showed that adding daratumumab to the standard two-drug regimen of bortezomib and dexamethasone markedly improved outcomes of patients with recurrent or refractory multiple myeloma.
Stephen Padilla, 5 days ago
Use of angiotensin converting enzyme inhibitors (ACEIs) appears to increase the risk of lung cancer, particularly among people using ACEIs for more than 5 years, suggests a recent study.

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
Naomi Rodrig, 15 Jun 2016
An interim analysis from the multinational phase III CASTOR trial, presented recently at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, showed that adding daratumumab to the standard two-drug regimen of bortezomib and dexamethasone markedly improved outcomes of patients with recurrent or refractory multiple myeloma.
Stephen Padilla, 5 days ago
Use of angiotensin converting enzyme inhibitors (ACEIs) appears to increase the risk of lung cancer, particularly among people using ACEIs for more than 5 years, suggests a recent study.