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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
30 May 2019
Frailty shares a relationship with subjective cognitive decline in elderly women, which appears before the incidence of overt dementia, a recent study has found.
05 Dec 2018
Traumatic brain injuries (TBI) appear to increase the risk of mortality among elderly adults with hip fractures, according to a recent study.
Jackey Suen, 29 Nov 2018

Early detection, intervention and adoption of a healthy lifestyle are the key to ending dementia, according to Professor Vincent Mok of the Division of Neurology, Faculty of Medicine, Chinese University of Hong Kong.

Jairia Dela Cruz, 23 May 2019
Dimethyl fumarate appears to prevent relapse more effectively in relapsing-remitting multiple sclerosis (RRMS) compared with teriflunomide, as shown in the results of a real-world study.