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.
Pearl Toh, 13 Jan 2020
Obeticholic acid significantly improves fibrosis and disease activity in patients with nonalcoholic steatohepatitis (NASH), a chronic liver disease currently with no approved therapy, according to an interim analysis of the landmark REGENERATE* study.
Stephen Padilla, 6 days ago
The Lancet Commission on Hypertension Group has recently released a position statement that contains a list of recommendations for the improvement of accuracy standards for devices that measure blood pressure (BP).

Original New Drug Application Approvals by US FDA (16 - 30 June 2019)

02 Jul 2019
New drug applications approved by US FDA as of 16 - 30 June 2019 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.

MYXREDLIN
  • Active Ingredient(s): Insulin human; sodium chloride
  • Strength:  100 mL; 9%
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Celerity Pharms
  • Approval Date: 20 June 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
  • Approved Label20 June 2019 (PDF)

VYLEESI
  • Active Ingredient(s): Bremelanotide acetate
  • Strength: 1.75 mg/0.3 mL
  • Dosage Form(s) / Route(s): Injectable; intravenous, subcutaneous
  • Company: Amag Pharms, Inc.
  • Approval Date: 21 June 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:
    • A co-existing medical or psychiatric condition,
    • Problems with the relationship, or
    • The effects of a medication or drug substance.
  • Approved Label21 June 2019 (PDF)

ZIRABEV
  • Active Ingredient(s): Bevacizumab-bvzr
  • Strength: 100 mg/4 mL; 400 mg/16 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Pfizer, Inc.
  • Approval Date: 27 June 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of:
    • Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.
    • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
  • Approved Label27 June 2019 (PDF)

THIOLA EC
  • Active Ingredient(s): Tiopronin
  • Strength: 100 mg; 300 mg
  • Dosage Form(s) / Route(s): Tablet, delayed release; oral
  • Company: Mission Pharmacal Co.
  • Approval Date: 28 June 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Not available
  • Approved Label: Not available
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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.
Pearl Toh, 13 Jan 2020
Obeticholic acid significantly improves fibrosis and disease activity in patients with nonalcoholic steatohepatitis (NASH), a chronic liver disease currently with no approved therapy, according to an interim analysis of the landmark REGENERATE* study.
Stephen Padilla, 6 days ago
The Lancet Commission on Hypertension Group has recently released a position statement that contains a list of recommendations for the improvement of accuracy standards for devices that measure blood pressure (BP).