Most Read Articles
Audrey Abella, 16 Oct 2019
The PD-1* inhibitor nivolumab showed significant survival benefit and a favourable safety profile than taxane chemotherapy in patients with unresectable advanced or recurrent oesophageal squamous cell carcinoma (OSCC) refractory or intolerant to previous fluoropyrimidine- and platinum-based chemotherapy, according to the findings of ATTRACTION-3** presented at ESMO 2019.
03 Oct 2019
Early enteral nutrition (EEN) speeds up the recovery of gastrointestinal function after laparoscopic common bile duct exploration (LCBDE), according to a study. However, EEN also increases complications such as diarrhoea and abdominal distension.
01 Sep 2019
A third of Clostridium difficile infection (CDI) patients with cirrhosis have been readmitted in a span of 30 days primarily due to recurrent CDI, a recent study has found. In addition, there is a high rate of mortality linked to CDI in patients with cirrhosis, in which a poor prognosis is predicted by decompensation and 30-day readmission.
26 Sep 2019
Use of proton pump inhibitors contributes to increased risk of cholangitis, a large cohort study suggests.

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)
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Most Read Articles
Audrey Abella, 16 Oct 2019
The PD-1* inhibitor nivolumab showed significant survival benefit and a favourable safety profile than taxane chemotherapy in patients with unresectable advanced or recurrent oesophageal squamous cell carcinoma (OSCC) refractory or intolerant to previous fluoropyrimidine- and platinum-based chemotherapy, according to the findings of ATTRACTION-3** presented at ESMO 2019.
03 Oct 2019
Early enteral nutrition (EEN) speeds up the recovery of gastrointestinal function after laparoscopic common bile duct exploration (LCBDE), according to a study. However, EEN also increases complications such as diarrhoea and abdominal distension.
01 Sep 2019
A third of Clostridium difficile infection (CDI) patients with cirrhosis have been readmitted in a span of 30 days primarily due to recurrent CDI, a recent study has found. In addition, there is a high rate of mortality linked to CDI in patients with cirrhosis, in which a poor prognosis is predicted by decompensation and 30-day readmission.
26 Sep 2019
Use of proton pump inhibitors contributes to increased risk of cholangitis, a large cohort study suggests.