Most Read Articles
Pearl Toh, 26 Sep 2019
The Singapore Health Sciences Authority (HSA) has recalled eight brands of ranitidine products containing trace amounts of the nitrosamine impurity NDMA*, which is a potential human carcinogen.
5 days ago
The use of folic acid in addition to enalapril in the treatment of patients with hypertension yields a modest increase in lifetime stroke-free survival, a study has found.
27 Sep 2019
Quadrivalent influenza vaccine (split virion, inactivated) 0.5 mL inj
Jairia Dela Cruz, 18 Jul 2018
Use of proton pump inhibitors and histamine‐2 receptor antagonists appears to reduce the risk of developing oesophageal carcinoma in patients with Barret’s oesophagus, according to a study.

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

01 Oct 2019
New drug applications approved by US FDA as of 16 - 30 September 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.

OZOBAX
  • Active Ingredient(s): Baclofen
  • Strength: 5mg/mL
  • Dosage Form(s) / Route(s): Solution; oral
  • Company: Metacal Pharma, LLC
  • Approval Date: 18 September 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s):
    • Indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
    • May also be of some value in patients with spinal cord injuries and other spinal cord diseases.
  • Approved Label18 September 2019 (PDF)

POTASSIUM PHOSPHATES
  • Active Ingredient(s): Potassium phosphates
  • Strength: 3 mmol/mL; 4.7 mEq/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: CMP Development, LLC
  • Approval Date: 19 September 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated as a source of phosphorus:
    • in intravenous fluids to correct hypophosphatemia in adults and pediatric patients 12 years of age and older when oral or enteral replacement is not possible, insufficient or contraindicated.
    • for parenteral nutrition in adults weighing at least 45 kg and pediatric patients 12 years of age and older weighing at least 40 kg when oral or enteral nutrition is not possible, insufficient or contraindicated.
  • Approved Label19 September 2019 (PDF)

RYBELSUS
  • Active Ingredient(s): Semaglutide
  • Strength: 3 mg; 7 mg; 14 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Novo Nordisk, Inc.
  • Approval Date: 20 September 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
  • Approved Label20 September 2019 (PDF)
Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Pharmacist - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
Pearl Toh, 26 Sep 2019
The Singapore Health Sciences Authority (HSA) has recalled eight brands of ranitidine products containing trace amounts of the nitrosamine impurity NDMA*, which is a potential human carcinogen.
5 days ago
The use of folic acid in addition to enalapril in the treatment of patients with hypertension yields a modest increase in lifetime stroke-free survival, a study has found.
27 Sep 2019
Quadrivalent influenza vaccine (split virion, inactivated) 0.5 mL inj
Jairia Dela Cruz, 18 Jul 2018
Use of proton pump inhibitors and histamine‐2 receptor antagonists appears to reduce the risk of developing oesophageal carcinoma in patients with Barret’s oesophagus, according to a study.