Most Read Articles
KY Leung, 01 Feb 2014

Group B Streptococcus (GBS) is the commonest cause of severe early-onset neonatal infection, which is associated with a high rate of morbidity and mortality (5–10%).1-3 About half of GBS meningitis will be complicated by neurodevelopment impairment. Because the early-onset disease develops shortly and rapidly after birth, there has been little improvement in the disease treatment, and the focus thus lies in disease prevention.

Jairia Dela Cruz, 23 Oct 2017
Evacuation proctography, magnetic resonance imaging, and transperineal and endovaginal ultrasonography demonstrate similar diagnostic test accuracy for posterior pelvic floor disorders in women with obstructed defecation syndrome, a recent study has shown.
Dr. Joseph Delano Fule Robles, 14 Oct 2016

Results of a recent clinical trial showed that treatment with niraparib, a poly ADP ribose polymerase (PARP) inhibitor,  improved progression-free survival (PFS) by more than 15 months in patients with recurrent ovarian cancer responding to platinum. 

Original New Drug Application Approvals by US FDA (1 - 15 May 2017)

15 May 2017
New drug applications approved by US FDA as of 1 - 15 May 2017 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.

STERITALC
  • Active Ingredient(s): TALC
  • Strength: 2MG, 3MG, 4MG
  • Dosage Form: Topical Powder
  • Company: Novatech SA
  • Approval Date: May 1, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated:
    • To decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion.
    • In adults to decrease the recurrence of pneumothorax
  • Approved Label: 05/01/2017 (PDF)

IMFINZI
  • Active Ingredient(s): DURVALUMAB
  • Strength: 50MG/ML
  • Dosage Form: Injectable; Injection
  • Company: Astrazeneca UK Ltd
  • Approval Date: May 1, 2017
  • Chemical Type: Not available
  • Indication(s): Indicated for the treatment of patients with:
    • Locally advanced or metastatic urothelial carcinoma who:
      • have disease progression during or following platinum-containing chemotherapy
      • have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
  • Approved Label: 05/01/2017 (PDF)

KISQALI; FEMARA
  • Active Ingredient(s): LETROZOLE;RIBOCICLIB
  • Strength: 200MG
  • Dosage Form: Oral Tablet
  • Company: Novartis Pharms Corp
  • Approval Date: May 4, 2017
  • Chemical Type: Type 4 - New Combination
  • Indication(s): Indicated as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
  • Approved Label: 05/04/2017 (PDF)

RADICAVA
  • Active Ingredient(s): EDARAVONE
  • Strength: 30MG/100ML
  • Dosage Form: Injectable; Injection
  • Company: Mitsubishi Tanabe Pharma Development America Inc
  • Approval Date: May 5, 2017
  • Chemical Type: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of amyotrophic lateral sclerosis (ALS)
  • Approved Label: 05/05/2017 (PDF)

MINOLIRA
  • Active Ingredient(s): MINOCYCLINE HYDROCHLORIDE
  • Strength: 105MG, 135MG
  • Dosage Form: Extended release oral tablet
  • Company: Dr Reddys Labs Ltd
  • Approval Date: May 8, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older
  • Approved Label: 05/05/2017 (PDF)

BAVENCIO
  • Active Ingredient(s): AVELUMAB
  • Strength: 20MG/ML
  • Dosage Form: Injectable; Intravenoues
  • Company: EMD Serono Inc
  • Approval Date: May 9, 2017
  • Chemical Type: Not available
  • Indication(s): Indicated for the treatment of:
    • Adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC)
    • Patients with locally advanced or metastatic urothelial carcinoma (UC) who:
      • Have disease progression during or following platinum-containing chemotherapy
      • Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
  • Approved Label: 05/09/2017 (PDF)
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Most Read Articles
KY Leung, 01 Feb 2014

Group B Streptococcus (GBS) is the commonest cause of severe early-onset neonatal infection, which is associated with a high rate of morbidity and mortality (5–10%).1-3 About half of GBS meningitis will be complicated by neurodevelopment impairment. Because the early-onset disease develops shortly and rapidly after birth, there has been little improvement in the disease treatment, and the focus thus lies in disease prevention.

Jairia Dela Cruz, 23 Oct 2017
Evacuation proctography, magnetic resonance imaging, and transperineal and endovaginal ultrasonography demonstrate similar diagnostic test accuracy for posterior pelvic floor disorders in women with obstructed defecation syndrome, a recent study has shown.
Dr. Joseph Delano Fule Robles, 14 Oct 2016

Results of a recent clinical trial showed that treatment with niraparib, a poly ADP ribose polymerase (PARP) inhibitor,  improved progression-free survival (PFS) by more than 15 months in patients with recurrent ovarian cancer responding to platinum.