Most Read Articles
Pearl Toh, 29 Jun 2020
Having migraine during midlife appears to be associated with a higher risk of developing dementia in later life, according to a large population-based longitudinal Danish study presented at the AHS* 2020 Virtual Meeting, indicating that migraine may be a risk factor for dementia.
29 Jun 2020
Use of the prescription stimulant methylphenidate appears to also exert a positive effect on the lower urinary tract in children with attention deficit hyperactivity disorder (ADHD) but without voiding dysfunction, specifically increasing voided volume and bladder capacity, as shown in a study.
Natalia Reoutova, 6 days ago

Consistent with the overall outcome of the phase III EF-14 study, elderly patients with newly diagnosed glioblastoma multiforme (GBM) treated with tumour-treating fields (TTFields) and temozolomide (TMZ) showed significantly better overall survival (OS) vs patients on TMZ alone, according to a post-hoc analysis presented at the American Association for cancer Research (AACR) 2020 Virtual Annual Meeting II.

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
Pearl Toh, 29 Jun 2020
Having migraine during midlife appears to be associated with a higher risk of developing dementia in later life, according to a large population-based longitudinal Danish study presented at the AHS* 2020 Virtual Meeting, indicating that migraine may be a risk factor for dementia.
29 Jun 2020
Use of the prescription stimulant methylphenidate appears to also exert a positive effect on the lower urinary tract in children with attention deficit hyperactivity disorder (ADHD) but without voiding dysfunction, specifically increasing voided volume and bladder capacity, as shown in a study.
Natalia Reoutova, 6 days ago

Consistent with the overall outcome of the phase III EF-14 study, elderly patients with newly diagnosed glioblastoma multiforme (GBM) treated with tumour-treating fields (TTFields) and temozolomide (TMZ) showed significantly better overall survival (OS) vs patients on TMZ alone, according to a post-hoc analysis presented at the American Association for cancer Research (AACR) 2020 Virtual Annual Meeting II.