Most Read Articles
01 Jun 2015
Long-term oral testosterone undecanoate significantly improved IPSS quality of life scores in a 1-year, randomised, multicentre, double-blind trial among aging hypogonadal men.
Rachel Soon, 01 Jun 2016

The inclusion of statins in managing chronic kidney disease (CKD) may help reduce patient mortality from stroke and possibly other cardiovascular events, according to an expert at the 7th Malaysian Endocrine and Metabolic Society (MEMS) Annual Congress.

Rachel Soon, 01 Jun 2016

Patients with hypercholesterolaemia with unchanging LDL-cholesterol levels after 6 weeks of statin treatment should be actively assessed for either statin intolerance or resistance, says an expert at the 7th Malaysian Endocrine and Metabolic Society (MEMS) Annual Congress.

Prof. Cyrus Rustam Kumana, 07 Jul 2016

This case scenario was presented at a grand round in the Department of Medicine, The University of Hong Kong. Unlike traditional grand rounds that directly or indirectly deal with clinical challenges posed by patients, this one was equally about doctors and how they care for their charges. All doctors who tend patients dread being implicated on the receiving end of medico-legal proceedings. This topic is therefore intimately linked to the professionalism of doctors, their standing in the community, and the ethical aspects of how they interact with patients and relatives.

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

15 Sep 2017
New drug applications approved by US FDA as of 1 - 15 September 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.

PALONOSETRON HYDROCHLORIDE
  • Active Ingredient(s): PALONOSETRON HYDROCHLORIDE
  • Strength: 0.25MG(BASE)/5ML(0.05MG(BASE)/ML
  • Dosage Form: Injectable; Injection
  • Company: Somerset Theraps LLC
  • Approval Date: September 1, 2017
  • Submission Classification: Not available
  • Indication(s): Not available
  • Approved Label: Not available

ADMELOG
  • Active Ingredient(s): INSULIN LISPRO
  • Strength: U-100
  • Dosage Form: Injectable; Injection
  • Company: Sanofi Aventis US
  • Approval Date: September 1, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for improving glycemic control in adults and children with diabetes mellitus
  • Approved Label: Not available

MYLOTARG
  • Active Ingredient(s): GEMTUZUMAB OZOGAMICIN
  • Strength: 4.5MG
  • Dosage Form: Single-dose vial
  • Company: Wyeth Pharms Inc
  • Approval Date: September 1, 2017
  • Submission Classification: Not available
  • Indication(s): Indicated for:
    • treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults
    • treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older
  • Approved Label: 09/01/2017 (PDF)

TRACLEER
  • Active Ingredient(s): BOSENTAN
  • Strength: 32MG
  • Dosage Form: Oral dispersable tablet
  • Company: Actelion Pharmaceuticals Ltd
  • Approval Date: September 5, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
    • in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to­-right shunts (18%)
    • in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability
  • Approved Label: 09/05/2017 (PDF)

DAPTOMYCIN
  • Active Ingredient(s): DAPTOMYCIN
  • Strength: 350MG
  • Dosage Form: Injectable; Injection
  • Company: Sagent Pharms
  • Approval Date: September 12, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for
    • Treatment of adult patients with complicated Skin and Skin Structure Infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only)
    • Treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia) in adult patients, including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates
  • Approved Label: Not available

ALIQOPA
  • Active Ingredient(s): COPANLISIB
  • Strength: 60MG
  • Dosage Form: Injectable;Injection
  • Company: Bayer Healthcare Pharms
  • Approval Date: September 14, 2017
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies
  • Approved Label: 09/14/2017 (PDF)

MVASI
  • Active Ingredient(s): BEVACIZUMAB-AWWB
  • Strength: 100MG/4ML (25MG/ML) | 400MG/16ML (25MG/ML)
  • Dosage Form: Injectable;Injection
  • Company: Amgen Inc
  • Approval Date: September 14, 2017
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of:
    • Metastatic colorectal cancer, with intravenous 5-fluorouracil–based chemotherapy for first- or second-line treatment
    • Metastatic colorectal cancer, with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen
    • Non-squamous non-small cell lung cancer, with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease
    • Glioblastoma, as a single agent for adult patients with progressive disease following prior therapy
      • Effectiveness based on improvement in objective response rate. No data available demonstrating improvement in disease-related symptoms or survival with bevacizumab products
    • Metastatic renal cell carcinoma with interferon alfa
    • Cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan in persistent, recurrent, or metastatic disease
  • Approved Label: 09/14/2017 (PDF)

ADZENYS ER
  • Active Ingredient(s): AMPHETAMINE
  • Strength: 1.25MG/ML
  • Dosage Form: Oral elixir solution
  • Company: Neos Theraps Inc
  • Approval Date: September 15, 2017
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.
  • Approved Label: 09/15/2017 (PDF)

SOLOSEC
  • Active Ingredient(s): SECNIDAZOLE
  • Strength: 2G
  • Dosage Form: Oral granule
  • Company: Symbiomix Therapeutics LLC
  • Approval Date: September 15, 2017
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of bacterial vaginosis in adult women
  • Approved Label: 09/15/2017 (PDF)

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Most Read Articles
01 Jun 2015
Long-term oral testosterone undecanoate significantly improved IPSS quality of life scores in a 1-year, randomised, multicentre, double-blind trial among aging hypogonadal men.
Rachel Soon, 01 Jun 2016

The inclusion of statins in managing chronic kidney disease (CKD) may help reduce patient mortality from stroke and possibly other cardiovascular events, according to an expert at the 7th Malaysian Endocrine and Metabolic Society (MEMS) Annual Congress.

Rachel Soon, 01 Jun 2016

Patients with hypercholesterolaemia with unchanging LDL-cholesterol levels after 6 weeks of statin treatment should be actively assessed for either statin intolerance or resistance, says an expert at the 7th Malaysian Endocrine and Metabolic Society (MEMS) Annual Congress.

Prof. Cyrus Rustam Kumana, 07 Jul 2016

This case scenario was presented at a grand round in the Department of Medicine, The University of Hong Kong. Unlike traditional grand rounds that directly or indirectly deal with clinical challenges posed by patients, this one was equally about doctors and how they care for their charges. All doctors who tend patients dread being implicated on the receiving end of medico-legal proceedings. This topic is therefore intimately linked to the professionalism of doctors, their standing in the community, and the ethical aspects of how they interact with patients and relatives.