Most Read Articles
Stephen Padilla, 28 Nov 2017
A dietary pattern rich in fresh and dried fruits, nuts and seeds, vegetable oils, and low-fat dairy products appears to lower the incidence rate of insulin resistance, according to an Iran study.
05 Oct 2017
Older men and women taking whey-protein drinks show a load-dependent slowing of gastric emptying and altered gut hormone secretion compared with controls, a recent study has found. However, whey protein does not appear to suppress subsequent ad libitum energy intake.

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
Stephen Padilla, 28 Nov 2017
A dietary pattern rich in fresh and dried fruits, nuts and seeds, vegetable oils, and low-fat dairy products appears to lower the incidence rate of insulin resistance, according to an Iran study.
05 Oct 2017
Older men and women taking whey-protein drinks show a load-dependent slowing of gastric emptying and altered gut hormone secretion compared with controls, a recent study has found. However, whey protein does not appear to suppress subsequent ad libitum energy intake.