Most Read Articles
Dr Margaret Shi, 4 days ago

The triplet regimen of encorafenib, binimetinib and cetuximab provides significant and clinically relevant benefits in overall survival (OS) and objective response rate (ORR) in patients with BRAFV600E-mutated metastatic colorectal cancer (mCRC) who experience disease progression after one or two previous regimens, according to results of an interim analysis of the BEACON CRC trial.

Pank Jit Sin, 30 Oct 2017
Barely has the dust settled on e-cigarettes before the next cigarette replacement product, based on the heat-not-burn (HNB) principle, emerges to derail tobacco control efforts. 
Natalia Reoutova, 18 Sep 2019

A retrospective analysis of seven clinical trials demonstrated that neratinib-based therapy is safe and effective in Asian patients with metastatic HER2-positive breast cancer.

3 days ago
New drug applications approved by US FDA as of 01 - 15 November 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. 

Original New Drug Application Approvals by US FDA (1- 15 October 2017)

16 Oct 2017
New drug applications approved by US FDA as of 1 - 15 October 2017 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.

ASCOR
  • Active Ingredient(s): ASCORBIC ACID
  • Strength: 500MG/ML
  • Dosage Form: Injectable;Injection
  • Company: Mcguff Pharmaceuticals Inc
  • Approval Date: October 2, 2017
  • Submission Classification: Type 7 - Drug Already Marketed without Approved NDA
  • Indication(s): Indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated
  • Approved Label: 10/02/2017 (PDF)

ZILRETTA
  • Active Ingredient(s): TRIAMCINOLONE ACETONIDE
  • Strength: 32MG
  • Dosage Form: Intramuscular extended-release injectable suspension
  • Company: Flexion Therapeutics Inc
  • Approval Date: October 6, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated as an intra-articular injection for the management of osteoarthritis pain of the knee
  • Approved Label: 10/06/2017 (PDF)

LYRICA CR
  • Active Ingredient(s): PREGABALIN
  • Strength: 82.5MG | 165MG | 330MG
  • Dosage Form: Extended release oral tablet
  • Company: Pfizer Inc
  • Approval Date: October 11, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the management of:
    • Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
    • Postherpetic neuralgia (PHN)
  • Approved Label: 10/11/2017 (PDF)

FOSAPREPITANT
  • Active Ingredient(s): FOSAPREPITANT
  • Strength: 150MG/VIAL
  • Dosage Form: Injectable;Injection
  • Company: Teva Pharms USA Inc
  • Approval Date: October 12, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the prevention of:
    • Acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin
    • Delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)
  • Approved Label: Not available
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Most Read Articles
Dr Margaret Shi, 4 days ago

The triplet regimen of encorafenib, binimetinib and cetuximab provides significant and clinically relevant benefits in overall survival (OS) and objective response rate (ORR) in patients with BRAFV600E-mutated metastatic colorectal cancer (mCRC) who experience disease progression after one or two previous regimens, according to results of an interim analysis of the BEACON CRC trial.

Pank Jit Sin, 30 Oct 2017
Barely has the dust settled on e-cigarettes before the next cigarette replacement product, based on the heat-not-burn (HNB) principle, emerges to derail tobacco control efforts. 
Natalia Reoutova, 18 Sep 2019

A retrospective analysis of seven clinical trials demonstrated that neratinib-based therapy is safe and effective in Asian patients with metastatic HER2-positive breast cancer.

3 days ago
New drug applications approved by US FDA as of 01 - 15 November 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.