Most Read Articles
Pearl Toh, 03 Jul 2020
After treatment with fremanezumab, a difficult-to-treat patient population with treatment-resistant episodic or chronic migraine saw sustained benefits across a broad range of measures, according to multiple analyses of the FOCUS study released during the AHS 2020 Virtual Meeting.
Pearl Toh, 24 Jun 2020
While aducanumab significantly reduced clinical decline in individuals with early Alzheimer's disease (AD) in one randomized trial, no changes were seen in another identical study — rendering the role of aducanumab in AD inconclusive.
Elvira Manzano, 24 Oct 2018
New evidence showed that a high-fat, low-carbohydrate ketogenic diet could help improve symptoms in patients with Parkinson's disease (PD), so did a low-fat, high-carbohydrate diet.
Pearl Toh, 01 Jul 2020
The CGRP* receptor blocker erenumab shows sustained efficacy in reducing migraine frequency over 2 years in a difficult-to-treat patient population with episodic migraine who had failed 2–4 prior preventive treatments, an interim analysis of the LIBERTY** open-label extension study shows.

Original New Drug Application Approvals by US FDA (01 - 15 May 2020)

15 May 2020
New drug applications approved by US FDA as of 01 - 15 May 2020 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.

FENSOLVI
  • Active Ingredient(s): Leuprolide acetate
  • Strength: 45 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Tolmar
  • Approval Date: 01 May 2020
  • Submission Classification: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
  • Indication(s): Indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty.
  • Approved Label01 May 2020 (PDF)

DARZALEX FASPRO
  • Active Ingredient(s): Daratumumab; hyaluronidase-fihj
  • Strength: 120 mg; 2,000 units/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Janssen Biotech
  • Approval Date: 01 May 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of adult patients with multiple myeloma:
    • in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant 
    • in combination with lenalidomide and dexamethasone in newly diagnosed patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
    • in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
    • as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
  • Approved Label01 May 2020 (PDF)

ELYXYB
  • Active Ingredient(s): Celecoxib
  • Strength: 120 mg/4.8 mL (25 mg/mL)
  • Dosage Form(s) / Route(s): Solution; oral
  • Company: Dr Reddys Labs, Ltd.
  • Approval Date: 05 May 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the acute treatment of migraine with or without aura in adults.
  • Approved Label05 May 2020 (PDF)

TABRECTA
  • Active Ingredient(s): Capmatinib
  • Strength: 150 mg; 200 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Novartis Pharms Corp
  • Approval Date: 06 May 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
  • Approved Label06 May 2020 (PDF)

RETEVMO
  • Active Ingredient(s): Selpeercatinib
  • Strength: 40 mg; 80 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Loxo Oncology, Inc.
  • Approval Date: 08 May 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of:
    • Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC)
    • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullarly thyroid cancer (MCT) who require systemic therapy
    • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemuc therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)
  • Approved Label08 May 2020 (PDF)

QINLOCK
  • Active Ingredient(s): Ripretinib
  • Strength: 150 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Deciphera Pharmaceuticals LLC
  • Approval Date: 15 May 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
  • Approved Label15 May 2020 (PDF)
Editor's Recommendations
Most Read Articles
Pearl Toh, 03 Jul 2020
After treatment with fremanezumab, a difficult-to-treat patient population with treatment-resistant episodic or chronic migraine saw sustained benefits across a broad range of measures, according to multiple analyses of the FOCUS study released during the AHS 2020 Virtual Meeting.
Pearl Toh, 24 Jun 2020
While aducanumab significantly reduced clinical decline in individuals with early Alzheimer's disease (AD) in one randomized trial, no changes were seen in another identical study — rendering the role of aducanumab in AD inconclusive.
Elvira Manzano, 24 Oct 2018
New evidence showed that a high-fat, low-carbohydrate ketogenic diet could help improve symptoms in patients with Parkinson's disease (PD), so did a low-fat, high-carbohydrate diet.
Pearl Toh, 01 Jul 2020
The CGRP* receptor blocker erenumab shows sustained efficacy in reducing migraine frequency over 2 years in a difficult-to-treat patient population with episodic migraine who had failed 2–4 prior preventive treatments, an interim analysis of the LIBERTY** open-label extension study shows.