Most Read Articles
Dr Margaret Shi, 18 May 2020

A blood test is shown to be feasible and safe for early detection of multiple cancers in women with no current or known history of cancer, enabling early treatment with curative intent in a subset of individuals.

Christina Lau, 20 Apr 2020

Hippocampal avoidance during whole-brain radiotherapy (HA-WBRT), together with memantine, better preserves cognitive function vs WBRT plus memantine in patients with brain metastases, without compromising survival, a multi-institutional phase III trial has shown.

Natalia Reoutova, 20 May 2020

Cancer patients infected with coronavirus disease 2019 (COVID-19) appear to be at higher risk of severe outcomes, including death, but cancer type and treatment serve as better predictors, according to recent research presented at the American Association for Cancer Research (AACR) 2020 Virtual Annual Meeting I.

At the time of writing, COVID-19 has spread to more than 200 countries and territories, affecting an estimated 4.5 million people and killing over 300,000. Cancer, on the other hand, is newly diagnosed in 18 million people and takes the lives of 10 million every year.

“We have invited physician scientists who are at the epicentre of the COVID-19 pandemic, taking care of patients with cancer. They gathered prospective information to understand the effects of COVID-19 on patients with cancer, are testing new treatments, and are making this knowledge available to the global research community, so we can all benefit from their experience,” said Professor Antoni Ribas from UCLA Medical Center, Los Angeles, California, US, chairperson of the COVID-19 and cancer plenary session of the meeting.

Natalia Reoutova, 28 May 2020

Fasting-mimicking diet (FMD) cycles in combination with endocrine therapy (ET) cause metabolic changes in hormone receptor (HR)-positive breast cancer patients analogous to those observed in animal models, where they are associated with anticancer activity.

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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Most Read Articles
Dr Margaret Shi, 18 May 2020

A blood test is shown to be feasible and safe for early detection of multiple cancers in women with no current or known history of cancer, enabling early treatment with curative intent in a subset of individuals.

Christina Lau, 20 Apr 2020

Hippocampal avoidance during whole-brain radiotherapy (HA-WBRT), together with memantine, better preserves cognitive function vs WBRT plus memantine in patients with brain metastases, without compromising survival, a multi-institutional phase III trial has shown.

Natalia Reoutova, 20 May 2020

Cancer patients infected with coronavirus disease 2019 (COVID-19) appear to be at higher risk of severe outcomes, including death, but cancer type and treatment serve as better predictors, according to recent research presented at the American Association for Cancer Research (AACR) 2020 Virtual Annual Meeting I.

At the time of writing, COVID-19 has spread to more than 200 countries and territories, affecting an estimated 4.5 million people and killing over 300,000. Cancer, on the other hand, is newly diagnosed in 18 million people and takes the lives of 10 million every year.

“We have invited physician scientists who are at the epicentre of the COVID-19 pandemic, taking care of patients with cancer. They gathered prospective information to understand the effects of COVID-19 on patients with cancer, are testing new treatments, and are making this knowledge available to the global research community, so we can all benefit from their experience,” said Professor Antoni Ribas from UCLA Medical Center, Los Angeles, California, US, chairperson of the COVID-19 and cancer plenary session of the meeting.

Natalia Reoutova, 28 May 2020

Fasting-mimicking diet (FMD) cycles in combination with endocrine therapy (ET) cause metabolic changes in hormone receptor (HR)-positive breast cancer patients analogous to those observed in animal models, where they are associated with anticancer activity.