Most Read Articles
Stephen Padilla, 3 days ago
Diabetic patients in a decompensated state and who develop type 2 myocardial infarction (MI) have an increased risk for mortality and major adverse cardiac events (MACE), according to a new study. In addition, these patients are potentially at risk for undiagnosed coronary artery disease.
5 days ago
Chocolate consumption is not associated with risk of coronary heart disease (CHD), stroke or both combined in postmenopausal women free of pre-existing major chronic disease, a study suggests.
Pearl Toh, 6 days ago
More intensive lowering of LDL-C levels was associated with a progressively greater survival benefit than less intensive approach, when the baseline LDL-C levels were ≥100 mg/dL, reveals a meta-analysis of 34 randomized trials.
5 days ago
Switching from thiazide diuretic to ipragliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, leads to improvements in metabolic parameters and body mass composition without affecting blood pressure in type 2 diabetes (T2D) patients, a recent study has found.

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
Stephen Padilla, 3 days ago
Diabetic patients in a decompensated state and who develop type 2 myocardial infarction (MI) have an increased risk for mortality and major adverse cardiac events (MACE), according to a new study. In addition, these patients are potentially at risk for undiagnosed coronary artery disease.
5 days ago
Chocolate consumption is not associated with risk of coronary heart disease (CHD), stroke or both combined in postmenopausal women free of pre-existing major chronic disease, a study suggests.
Pearl Toh, 6 days ago
More intensive lowering of LDL-C levels was associated with a progressively greater survival benefit than less intensive approach, when the baseline LDL-C levels were ≥100 mg/dL, reveals a meta-analysis of 34 randomized trials.
5 days ago
Switching from thiazide diuretic to ipragliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, leads to improvements in metabolic parameters and body mass composition without affecting blood pressure in type 2 diabetes (T2D) patients, a recent study has found.