Most Read Articles
Dr. Wong Soon Tee, 28 May 2020
Acne is a common skin problem seen in primary care. Dr Wong Soon Tee of Assurance Skin Clinic at Mt Elizabeth Novena Hospital, Singapore shares his insights with Pearl Toh on how to manage acne in the primary care setting.
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.
Rachel Soon, 24 Apr 2019

With recent recalls of losartan-containing products contaminated by potentially carcinogenic nitrosamines, MIMS speaks to the Malaysian National Pharmaceutical Regulatory Agency (NPRA) for more details.

Roshini Claire Anthony, 25 Jun 2020

Patients with rheumatoid arthritis (RA) treated with tumour necrosis factor (TNF) inhibitors may have a reduced risk of venous thromboembolism (VTE) compared with those treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), according to an observational study presented at EULAR 2020.

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
Dr. Wong Soon Tee, 28 May 2020
Acne is a common skin problem seen in primary care. Dr Wong Soon Tee of Assurance Skin Clinic at Mt Elizabeth Novena Hospital, Singapore shares his insights with Pearl Toh on how to manage acne in the primary care setting.
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.
Rachel Soon, 24 Apr 2019

With recent recalls of losartan-containing products contaminated by potentially carcinogenic nitrosamines, MIMS speaks to the Malaysian National Pharmaceutical Regulatory Agency (NPRA) for more details.

Roshini Claire Anthony, 25 Jun 2020

Patients with rheumatoid arthritis (RA) treated with tumour necrosis factor (TNF) inhibitors may have a reduced risk of venous thromboembolism (VTE) compared with those treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), according to an observational study presented at EULAR 2020.