Most Read Articles
16 Nov 2018
Among offspring of parents with bipolar disorder (OBP), resting-state functional connectivity (rsFC) between left inferior frontal gyrus (IFG) and clusters in the left insula (LINS) may be a risk marker for the development of bipolar disorder, suggests a study.
Stephen Padilla, 02 Apr 2019
Exposure to ambient pesticides within 2,000 m of the mother’s residence during pregnancy increases the risk of autism spectrum disorder (ASD) in offspring, suggests a study. Moreover, risks for ASD with comorbid intellectual disability are further increased when infant is exposed to pesticides.
12 May 2019
A consistent association exists between perinatal maternal depressive symptoms and child brain development assessed 10 years later, suggests a recent study.
Stephen Padilla, 05 Apr 2019
Nonsurgical brain stimulation techniques may serve as alternative or add-on treatments for adults with major depressive episodes, suggest the results of a systematic review and network meta-analysis.

Original New Drug Application Approvals by US FDA (15 - 30 September 2018)

30 Sep 2018
New drug applications approved by US FDA as of 15 - 30 September 2018 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.

COPIKTRA
  • Active Ingredient(s): Duvelisib
  • Strength: 15MG; 25MG
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: Verastem Inc
  • Approval Date: 24 Sep 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with:
    • Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies
    • Relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
  • Approved Label24 Sep 2018 (PDF)
VIZIMPRO
  • Active Ingredient(s): Dacomitinib
  • Strength: 15MG; 30MG; 45MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Pfizer Inc
  • Approval Date: 27 Sep 2018
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
  • Approved Label27 Sep 2018 (PDF)
EMGALITY
  • Active Ingredient(s): Galcanezumab-gnlm
  • Strength: 120MG/ML
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Eli Lilly and Co
  • Approval Date: 27 Sep 2018
  • Submission Classification: Not available
  • Indication(s): Indicated for the preventive treatment of migraine in adults.
  • Approved Label27 Sep 2018 (PDF)
ARIKAYCE
  • Active Ingredient(s): Amikacin
  • Strength: 590MG
  • Dosage Form(s) / Route(s): Suspension; Inhalation
  • Company: Insmed
  • Approval Date: 28 Sep 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients.
  • Approved Label28 Sep 2018 (PDF)
LIBTAYO
  • Active Ingredient(s): Cemiplimab-rwlc
  • Strength: 350MG
  • Dosage Form(s) / Route(s): Injectable; Intravenous
  • Company: Regeneron Pharmaceuticals
  • Approval Date: 28 Sep 2018
  • Submission Classification: Not available
  • Indication(s): Not available
  • Approved Label: Not available
Editor's Recommendations
Most Read Articles
16 Nov 2018
Among offspring of parents with bipolar disorder (OBP), resting-state functional connectivity (rsFC) between left inferior frontal gyrus (IFG) and clusters in the left insula (LINS) may be a risk marker for the development of bipolar disorder, suggests a study.
Stephen Padilla, 02 Apr 2019
Exposure to ambient pesticides within 2,000 m of the mother’s residence during pregnancy increases the risk of autism spectrum disorder (ASD) in offspring, suggests a study. Moreover, risks for ASD with comorbid intellectual disability are further increased when infant is exposed to pesticides.
12 May 2019
A consistent association exists between perinatal maternal depressive symptoms and child brain development assessed 10 years later, suggests a recent study.
Stephen Padilla, 05 Apr 2019
Nonsurgical brain stimulation techniques may serve as alternative or add-on treatments for adults with major depressive episodes, suggest the results of a systematic review and network meta-analysis.