Most Read Articles
Roshini Claire Anthony, 07 Nov 2017

Women who are underweight, particularly in their late teens and mid-thirties, may be at risk for early menopause, a recent study found. 

5 days ago
Oestradiol therapy appears to protect certain types of cognition in the presence of stress, suggests a recent study.
17 May 2017
The high-concentration capsaicin patch shows promise in the management of painful diabetic peripheral neuropathy (PDPN), with an effect that is similar to that observed with oral agents but offering systemic tolerability benefits, according to a network meta-analysis.
Audrey Abella, 20 Jan 2017
Diabetes was not a risk factor for total knee replacement (TKR) due to severe knee osteoarthritis, a Singapore study found.

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
Roshini Claire Anthony, 07 Nov 2017

Women who are underweight, particularly in their late teens and mid-thirties, may be at risk for early menopause, a recent study found. 

5 days ago
Oestradiol therapy appears to protect certain types of cognition in the presence of stress, suggests a recent study.
17 May 2017
The high-concentration capsaicin patch shows promise in the management of painful diabetic peripheral neuropathy (PDPN), with an effect that is similar to that observed with oral agents but offering systemic tolerability benefits, according to a network meta-analysis.
Audrey Abella, 20 Jan 2017
Diabetes was not a risk factor for total knee replacement (TKR) due to severe knee osteoarthritis, a Singapore study found.