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 (16 - 30 June 2017)

01 Aug 2017
New drug applications approved by US FDA as of 16 - 30 June 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.

COTEMPLA XR-ODT
  • Active Ingredient(s): METHYLPHENIDATE
  • Strength: 8.6MG;  17.3MG; 25.9MG
  • Dosage Form: Disintegrating Extended-Release Oral Tablet
  • Company: Neos Theraps Inc
  • Approval Date: June 19, 2017
  • Chemical Type: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age
  • Approved Label: 06/19/2017 (PDF)

BAXDELA
  • Active Ingredient(s): DELAFLOXACIN MEGLUMINE
  • Strength: EQ 450MG BASE
  • Dosage Form: Oral Tablet
  • Company: Melinta Theraps Inc
  • Approval Date: June 19, 2017
  • Chemical Type: Type 1 - New Molecular Entity
  • Indication(s): Indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria
  • Approved Label: 06/19/2017 (PDF)

BAXDELA
  • Active Ingredient(s): DELAFLOXACIN MEGLUMINE
  • Strength: EQ 300MG BASE/VIAL
  • Dosage Form: IV (infusion) powder
  • Company: Melinta Theraps Inc
  • Approval Date: June 19, 2017
  • Chemical Type: Type 1 - New Molecular Entity
  • Indication(s): Indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria
  • Approved Label: 06/19/2017 (PDF)

MYDAYIS
  • Active Ingredient(s): AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
  • Strength: 3.125MG;3.125MG;3.125MG;3.125MG | 6.25MG;6.25MG;6.25MG;6.25MG | 9.375MG;9.375MG;9.375MG;9.375MG | 12.5MG;12.5MG;12.5MG;12.5MG
  • Dosage Form: Extended-release Oral Capsule
  • Company: Shire Dev LLC
  • Approval Date: June 20, 2017
  • Chemical Type: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older
  • Approved Label: 06/20/2017 (PDF)

RITUXAN HYCELA
  • Active Ingredient(s): HYALURONIDASE;RITUXIMAB
  • Strength: 1400MG and 23400UNITS/11.7ML |  1600MG and 26800UNITS/13.4ML
  • Dosage Form: Injectable; Injection
  • Company: Genentech Inc
  • Approval Date: June 22, 2017
  • Chemical Type: Not available
  • Indication(s): Indicated the treatment of adult patients with:
    • Follicular Lymphoma (FL)
      • Relapsed or refractory, follicular lymphoma as a single agent
      • Previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy
      • Non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy
    • Diffuse Large B-cell Lymphoma (DLBCL)
      • Previously untreated diffuse large B-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens
    • Chronic Lymphocytic Leukemia (CLL)
      • Previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide
  • Approved Label: 06/22/2017 (PDF)

BEVYXXA
  • Active Ingredient(s): BETRIXABAN
  • Strength: 40MG | 80MG
  • Dosage Form: Oral Capsule
  • Company: Portola Pharms Inc
  • Approval Date: June 23, 2017
  • Chemical Type: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE
  • Approved Label: 06/23/2017 (PDF)

TRIPTODUR KIT
  • Active Ingredient(s): TRIPTORELIN PAMOATE
  • Strength: EQ 22.5MG BASE/VIAL
  • Dosage Form: Extended-release Intramuscular for Suspension
  • Company: Arbor Pharms LLC
  • Approval Date: June 29, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of pediatric patients 2 years and older with central precocious puberty
  • Approved Label: 06/29/2017 (PDF)

EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE
  • Active Ingredient(s): EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE
  • Strength: 600MG;300MG;300MG
  • Dosage Form: Oral tablet
  • Company: Hetero Drugs LTD
  • Approval Date: June 30 2017
  • Chemical Type: Type 4 - New Combination
  • Indication(s): Indicated for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg
  • Approved Label: Not available

PANTOPRAZOLE SODIUM
  • Active Ingredient(s): PANTOPRAZOLE SODIUM
  • Strength: EQ 40MG BASE/VIAL
  • Dosage Form: IV (infusion) Powder
  • Company: Exela Pharma SCS LLC
  • Approval Date: June 30, 2017
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in adults for the following:
    • Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a historyof erosive esophagitis (EE)
    • Pathological hypersecretion conditions, including Zollinger-Ellison (ZE) syndrome
  • Approved Label: 06/30/2017 (PDF)
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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.