Most Read Articles
09 Jan 2019
Despite comparable efficacies, triamcinolone injections appear to be slightly superior over 5-fluorouracil injections for inducing keloid remission, a recent trial has found.
Jairia Dela Cruz, 5 days ago
Use of standard-dose aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) appears to confer protection against the risk of endometrial cancer in overweight and obese women, according to a meta-analysis.
Tristan Manalac, 5 days ago
Less than 15 percent of Singaporean adolescents get the recommended 8–10 hours of sleep on a school night, reports a recent study, noting that such short sleep duration is linked to symptoms of depression, overweight or obesity, and poorer self-rated health.
04 Jan 2019
Obstructive sleep apnoea may increase the risk of male-pattern baldness in men with a family history of hair loss, and this association appears to be mediated by low serum transferrin saturation levels related to hypoxia, a study suggests.

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
09 Jan 2019
Despite comparable efficacies, triamcinolone injections appear to be slightly superior over 5-fluorouracil injections for inducing keloid remission, a recent trial has found.
Jairia Dela Cruz, 5 days ago
Use of standard-dose aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) appears to confer protection against the risk of endometrial cancer in overweight and obese women, according to a meta-analysis.
Tristan Manalac, 5 days ago
Less than 15 percent of Singaporean adolescents get the recommended 8–10 hours of sleep on a school night, reports a recent study, noting that such short sleep duration is linked to symptoms of depression, overweight or obesity, and poorer self-rated health.
04 Jan 2019
Obstructive sleep apnoea may increase the risk of male-pattern baldness in men with a family history of hair loss, and this association appears to be mediated by low serum transferrin saturation levels related to hypoxia, a study suggests.