Most Read Articles
15 Mar 2019
Roche recently announced their targeted therapy combination pertuzumab (Perjeta®)-trastuzumab (Herceptin®) plus conventional chemotherapy for treatment of early breast cancer in those with a subtype known as HER2-positive. The combination was previously used in the metastatic breast cancer setting, where cancer had already spread. There, it was able to prolong cancer sufferers’ lives significantly. Because of its effectiveness, the two-drug combo is new available for treatment of early HER2-positive breast cancer to further reduce the risk of metastasis or cancer recurrence. HER2-positive breast cancers usually spread faster and affect younger women and make up about one quarter of all newly diagnosed breast cancers. 

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
15 Mar 2019
Roche recently announced their targeted therapy combination pertuzumab (Perjeta®)-trastuzumab (Herceptin®) plus conventional chemotherapy for treatment of early breast cancer in those with a subtype known as HER2-positive. The combination was previously used in the metastatic breast cancer setting, where cancer had already spread. There, it was able to prolong cancer sufferers’ lives significantly. Because of its effectiveness, the two-drug combo is new available for treatment of early HER2-positive breast cancer to further reduce the risk of metastasis or cancer recurrence. HER2-positive breast cancers usually spread faster and affect younger women and make up about one quarter of all newly diagnosed breast cancers.