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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
Natalia Reoutova, 6 days ago
A recently published study involving 4,517 individuals confirmed the role of BRCA2 mutations in genetic predisposition to oesophageal squamous cell carcinoma (OSCC) among Chinese.