Most Read Articles
Stephen Padilla, 05 Jan 2018
The addition of an antihypertensive drug from a new class to a patient’s regimen results in huge decreases in systolic blood pressure (SBP) and major cardiovascular (CV) events among those at high risk for CV events but without diabetes, suggests a recent study. Its effects on SBP remain large and similar in magnitude across all levels of baseline drug use and all subgroups of patients.
Pearl Toh, 4 days ago
A study finds no evidence that using pharmaceutical aids alone for smoking cessation helps improve the chances of successful quitting despite promising results in previous randomized trials and routine prescription of such drugs to help quit smoking.
Yesterday
The risk of stroke and subsequent mortality is significantly elevated in patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD), a recent study has shown.
Roshini Claire Anthony, 10 Jan 2018

Adding rifampicin to standard antibiotic therapy does not improve outcomes in individuals with Staphylococcus aureus (S. aureus) bacteraemia, the ARREST* trial shows. However, rifampicin may contribute towards a minor reduction in bacteraemia recurrence.

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

28 Jul 2017
New drug applications approved by US FDA as of 1 - 15 July 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.

OMEPRAZOLE
  • Active Ingredient(s): OMEPRAZOLE
  • Strength: 20MG
  • Dosage Form: Oral Disintegrating extended-release tablet
  • Company: Dexcel Pharma
  • Approval Date: July 5, 2017
  • Chemical Type: Type 8 - Partial Rx to OTC Switch
  • Indication(s): Indicated for the treatment of frequent heartburn (occurs 2 or more days a week)
  • Approved Label: 07/05/2017 (PDF)

ENDARI
  • Active Ingredient(s): L-GLUTAMINE
  • Strength: 5G
  • Dosage Form: Oral Powder
  • Company: Emmaus Medcl
  • Approval Date: July 7, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older
  • Approved Label: 07/07/2017 (PDF)

TREMFYA
  • Active Ingredient(s): GUSELKUMAB
  • Strength: 100MG/ML
  • Dosage Form: Injectable; Injection
  • Company: Janssen Biotech
  • Approval Date: July 13, 2017
  • Chemical Type: Not available
  • Indication(s): Indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
  • Approved Label: 07/13/2017 (PDF)

ZYPITAMAG
  • Active Ingredient(s): PITAVASTATIN
  • Strength: 1MG, 2MG, 4MG
  • Dosage Form: Oral Tablet
  • Company: Zydus Pharms USA Inc
  • Approval Date: July 14, 2017
  • Chemical Type: Type 2 - New Active Ingredient
  • Indication(s): Indicated for patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C)
  • Approved Label: 07/14/2017 (PDF)
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Most Read Articles
Stephen Padilla, 05 Jan 2018
The addition of an antihypertensive drug from a new class to a patient’s regimen results in huge decreases in systolic blood pressure (SBP) and major cardiovascular (CV) events among those at high risk for CV events but without diabetes, suggests a recent study. Its effects on SBP remain large and similar in magnitude across all levels of baseline drug use and all subgroups of patients.
Pearl Toh, 4 days ago
A study finds no evidence that using pharmaceutical aids alone for smoking cessation helps improve the chances of successful quitting despite promising results in previous randomized trials and routine prescription of such drugs to help quit smoking.
Yesterday
The risk of stroke and subsequent mortality is significantly elevated in patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD), a recent study has shown.
Roshini Claire Anthony, 10 Jan 2018

Adding rifampicin to standard antibiotic therapy does not improve outcomes in individuals with Staphylococcus aureus (S. aureus) bacteraemia, the ARREST* trial shows. However, rifampicin may contribute towards a minor reduction in bacteraemia recurrence.