Most Read Articles
Pearl Toh, 31 Dec 2019
Adding the neuraminidase inhibitor oseltamivir to usual care speeds up recovery from influenza-like illness by a day compared with usual care alone, with even greater benefits seen in older, sicker patients with comorbidities, according to the ALIC4E study.
23 Dec 2019
At a Menarini-sponsored symposium held during the Asian Pacific Society Congress, renowned cardiologist Prof John Camm provided the latest evidence for chronic stable angina with or without concomitant diseases, with a special focus on the antianginal agent ranolazine and combination therapies. The event was chaired and moderated by Dr Dante Morales from the University of the Philippines College of Medicine.
09 Jan 2020
Acute ischaemic stroke patients who are current or recent smokers are at greater odds of having unfavourable functional outcomes 3 months after the index event, a study has found.
Stephen Padilla, 3 days ago
Brodalumab has exhibited long-term efficacy and consistent safety profile for more than 2 years in the treatment of patients with psoriasis, results of the phase III AMAGINE-2 trial show.

Original New Drug Application Approvals by US FDA (16 - 31 January 2018)

31 Jan 2018

New drug applications approved by US FDA as of 16-31 January 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.

CABAZITAXEL INJECTION

  • Active Ingredient(s): Cabazitaxel
  • Strength: 40mg/4ml, 60mg/6ml
  • Dosage Form: Injectable;injection
  • Company: Actavis LLC
  • Approval Date: January 17, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not available
  • Approved Label: Not available

TIGECYCLINE
  • Active Ingredient(s): Tigecycline
  • Strength: 50 mg
  • Dosage Form: Injectable;injection
  • Company: Accord Hlthcare Inc
  • Approval Date: January 18, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated  in patients 18 years of age and older for:
    • Complicated skin and skin structure infections.
    • Complicated intra-abdominal infections.
    • Community-acquired bacterial pneumonia.
  • Approved Label: 01/18/2018(PDF)
LUTATHERA
  • Active Ingredient(s): Lutetium LU 177 Dotatate
  • Strength: 370 mbq/ml
  • Dosage Form: Injectable;injection
  • Company: Advanced Accelerator Applications USA Inc
  • Approval Date: January 26, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of somastatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.
  • Approved Label: 01/26/2018(PDF)
Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Doctor - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
Pearl Toh, 31 Dec 2019
Adding the neuraminidase inhibitor oseltamivir to usual care speeds up recovery from influenza-like illness by a day compared with usual care alone, with even greater benefits seen in older, sicker patients with comorbidities, according to the ALIC4E study.
23 Dec 2019
At a Menarini-sponsored symposium held during the Asian Pacific Society Congress, renowned cardiologist Prof John Camm provided the latest evidence for chronic stable angina with or without concomitant diseases, with a special focus on the antianginal agent ranolazine and combination therapies. The event was chaired and moderated by Dr Dante Morales from the University of the Philippines College of Medicine.
09 Jan 2020
Acute ischaemic stroke patients who are current or recent smokers are at greater odds of having unfavourable functional outcomes 3 months after the index event, a study has found.
Stephen Padilla, 3 days ago
Brodalumab has exhibited long-term efficacy and consistent safety profile for more than 2 years in the treatment of patients with psoriasis, results of the phase III AMAGINE-2 trial show.