Most Read Articles
Stephen Padilla, 12 Dec 2019
Transitioning from bortezomib- to ixazomib-based induction is feasible, tolerable and effective in the treatment of community patients with newly diagnosed multiple myeloma (NDMM), according to a study presented at the 61st Annual Meeting of the American Society of Hematology (ASH 2019).
10 Mar 2017
The addition of pravastatin to standard chemotherapy does not improve outcomes in patients with small-cell lung cancer (SCLC), results of a study have shown.
Jackey Suen, 24 Feb 2017

Research on the role of circulating tumour DNA (ctDNA) in metastatic castration-resistant prostate cancer (mCRPC) gains momentum, as a new study finds ctDNA assessment promising in the monitoring and prognosis of mCRPC and in identifying new therapeutic targets for the disease.

13 Feb 2020
At the recent National Haematology Expert Meeting 2019, a panel of experts was convened to discuss the role of targeted therapy in the management of haematological malignancies. Highlights of their lectures are summarised below.

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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Editor's Recommendations
Most Read Articles
Stephen Padilla, 12 Dec 2019
Transitioning from bortezomib- to ixazomib-based induction is feasible, tolerable and effective in the treatment of community patients with newly diagnosed multiple myeloma (NDMM), according to a study presented at the 61st Annual Meeting of the American Society of Hematology (ASH 2019).
10 Mar 2017
The addition of pravastatin to standard chemotherapy does not improve outcomes in patients with small-cell lung cancer (SCLC), results of a study have shown.
Jackey Suen, 24 Feb 2017

Research on the role of circulating tumour DNA (ctDNA) in metastatic castration-resistant prostate cancer (mCRPC) gains momentum, as a new study finds ctDNA assessment promising in the monitoring and prognosis of mCRPC and in identifying new therapeutic targets for the disease.

13 Feb 2020
At the recent National Haematology Expert Meeting 2019, a panel of experts was convened to discuss the role of targeted therapy in the management of haematological malignancies. Highlights of their lectures are summarised below.