Original New Drug Application Approvals by US FDA (01 - 15 March 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 Label: 05 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 Label: 11 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)