Most Read Articles
11 Apr 2019
Cannabis use disorder appears to exert a beneficial effect on the risk of disorders of gut–brain interaction and inflammatory bowel disease in patients with schizophrenia but not in population controls, a study has found. This finding raises the possibility of new targets for treatment and prevention of digestive organ disorders in schizophrenia.
10 Apr 2019
An individualized, food-based diet may be a potential treatment approach for patients with active Crohn’s disease, successfully replicating microbiome changes elicited by exclusive enteral nutrition and reducing gut inflammation, a recent study has shown.
12 Nov 2018
Individuals with severe and frequent gastro-oesophageal reflux disease (GERD) are at increased risk of Barrett’s oesophagus (BE), especially in the absence of frequent proton pump inhibitor (PPI) use, a recent study has found. Family history of BE and early age of symptom onset are strong predictors of BE among people with GERD.

Original New Drug Application Approvals by US FDA (01- 15 December 2018)

15 Dec 2018
New drug applications approved by US FDA as of 01- 15 December 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.

TOLSURA
  • Active Ingredient(s): Itraconazole
  • Strength: 65 MG
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: Mayne Pharma Inc
  • Approval Date: 11 Dec 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised adult patients:
    • Blastomycosis, pulmonary and extrapulmonary
    • Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and
    • Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy.
  • Approved Label: 11 Dec 2018 (PDF)

MOTEGRITY
  • Active Ingredient(s): Prucalopride
  • Strength: 1MG; 2MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Shire Dev LLC
  • Approval Date: 14 Dec 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of chronic idiopathic constipation (CIC) in adults
  • Approved Label: 14 Dec 2018 (PDF)

HERZUMA
  • Active Ingredient(s): Trastuzumab-pkrb
  • Strength: 420MG
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Celltrion Inc
  • Approval Date: 14 Dec 2018
  • Submission Classification: Not Available
  • Indication(s): Indicated for the treatment of HER2-overexpressing breast cancer.
  • Approved Label: 14 Dec 2018 (PDF)
Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Gastroenterology - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
11 Apr 2019
Cannabis use disorder appears to exert a beneficial effect on the risk of disorders of gut–brain interaction and inflammatory bowel disease in patients with schizophrenia but not in population controls, a study has found. This finding raises the possibility of new targets for treatment and prevention of digestive organ disorders in schizophrenia.
10 Apr 2019
An individualized, food-based diet may be a potential treatment approach for patients with active Crohn’s disease, successfully replicating microbiome changes elicited by exclusive enteral nutrition and reducing gut inflammation, a recent study has shown.
12 Nov 2018
Individuals with severe and frequent gastro-oesophageal reflux disease (GERD) are at increased risk of Barrett’s oesophagus (BE), especially in the absence of frequent proton pump inhibitor (PPI) use, a recent study has found. Family history of BE and early age of symptom onset are strong predictors of BE among people with GERD.