Most Read Articles
Dr. Joseph Delano Fule Robles, 06 May 2019

Gilteritinib, a novel inhibitor of the tyrosine kinase FLT3, improves survival outcomes among patients with relapsed or refractory acute myeloid leukaemia (AML) with FLT3 mutations vs standard chemotherapy, according to results of the phase III ADMIRAL trial reported at the American Association for Cancer Research (AACR) Annual Meeting 2019 held in Atlanta, Georgia, US.

Roshini Claire Anthony, 30 Apr 2019

Patients with advanced small cell lung cancer (SCLC) who experience disease progression despite two or more lines of therapy could benefit from pembrolizumab in the third-line setting, according to results from the phase 1b KEYNOTE-028 and phase II KEYNOTE-158* studies presented at AACR 2019.

Original New Drug Application Approvals by US FDA (01 - 15 March 2019)

15 Mar 2019
New drug applications approved by US FDA as of 01 - 15 March 2019 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.

SPRAVATO
  • Active Ingredient(s): Esketamine
  • Strength: 56 mg; 84 mg
  • Dosage Form(s) / Route(s): Spray; Nasal
  • Company: Janssen Pharms
  • Approval Date: 05 Mar 2019
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression (TRD) in adults.
  • Approved Label05 Mar 2019 (PDF)

TRAZIMERA
  • Active Ingredient(s): Trastuzumab-qyyp
  • Strength: 420 mg
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Pfizer Inc
  • Approval Date: 11 Mar 2019
  • Submission Classification: Not Available
  • Indication(s): Indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression (TRD) in adults.
    • The treatment of HER2-overexpressing breast cancer.
    • The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
  • Approved Label11 Mar 2019 (PDF)

ROCKLATAN
  • Active Ingredient(s): Netarsudil; Latanoprost
  • Strength: 0.02%; 0.005%
  • Dosage Form(s) / Route(s): Solution; Ophthalmic
  • Company: Aerie Pharms Inc
  • Approval Date: 12 Mar 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
  • Approved Label: 12 Mar 2019 (PDF)

TETRACAINE HYDROCHLORIDE
  • Active Ingredient(s): Tetracaine hydrochloride
  • Strength: 5%
  • Dosage Form(s) / Route(s): Solution; Ophthalmic
  • Company: Paragon Bioteck
  • Approval Date: 12 Mar 2019
  • Submission Classification:
  • Indication(s): Indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.
  • Approved Label: 12 Mar 2019 (PDF)
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Most Read Articles
Dr. Joseph Delano Fule Robles, 06 May 2019

Gilteritinib, a novel inhibitor of the tyrosine kinase FLT3, improves survival outcomes among patients with relapsed or refractory acute myeloid leukaemia (AML) with FLT3 mutations vs standard chemotherapy, according to results of the phase III ADMIRAL trial reported at the American Association for Cancer Research (AACR) Annual Meeting 2019 held in Atlanta, Georgia, US.

Roshini Claire Anthony, 30 Apr 2019

Patients with advanced small cell lung cancer (SCLC) who experience disease progression despite two or more lines of therapy could benefit from pembrolizumab in the third-line setting, according to results from the phase 1b KEYNOTE-028 and phase II KEYNOTE-158* studies presented at AACR 2019.