Most Read Articles
Audrey Abella, 15 May 2020
In adults with atrial fibrillation (AF) after percutaneous coronary intervention (PCI), dual therapy (direct oral anticoagulant [DOAC] + P2Y12 inhibitor) reduces the risk of bleeding compared with triple therapy (vitamin K antagonist [VKA] + DAPT* [aspirin and P2Y12 inhibitor]), a meta-analysis has shown. However, its effects on the risks of mortality and ischaemic endpoints** remain unclear.
09 May 2020
Use of aspirin during the implantation window of the menstrual cycle appears to increase fecundability, reveals a recent study.
31 Mar 2020
When treating fibromyalgia patients with low-dose naltrexone, the 4.5-mg dose appears to be a good choice, according to a recent study.
Pearl Toh, 11 Jun 2019
The novel antibody-drug conjugate enfortumab vedotin showed promising clinical activity in patients with advanced and metastatic urothelial cancer for whom there is a high unmet need, according to the EV-201 study presented at the ASCO 2019 Meeting.

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)
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Most Read Articles
Audrey Abella, 15 May 2020
In adults with atrial fibrillation (AF) after percutaneous coronary intervention (PCI), dual therapy (direct oral anticoagulant [DOAC] + P2Y12 inhibitor) reduces the risk of bleeding compared with triple therapy (vitamin K antagonist [VKA] + DAPT* [aspirin and P2Y12 inhibitor]), a meta-analysis has shown. However, its effects on the risks of mortality and ischaemic endpoints** remain unclear.
09 May 2020
Use of aspirin during the implantation window of the menstrual cycle appears to increase fecundability, reveals a recent study.
31 Mar 2020
When treating fibromyalgia patients with low-dose naltrexone, the 4.5-mg dose appears to be a good choice, according to a recent study.
Pearl Toh, 11 Jun 2019
The novel antibody-drug conjugate enfortumab vedotin showed promising clinical activity in patients with advanced and metastatic urothelial cancer for whom there is a high unmet need, according to the EV-201 study presented at the ASCO 2019 Meeting.