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Roshini Claire Anthony, 6 days ago

For coffee drinkers, drinking filtered coffee may be tied to a lower mortality risk, including cardiovascular disease (CVD)-related mortality, a study from Norway suggested.

4 days ago
Use of corticosteroid is not associated with improved outcomes in idiopathic pulmonary fibrosis (IPF) patients admitted to the hospital with acute exacerbation (AE), reveals a recent study. In addition, corticosteroids may even contribute to reduced overall survival following exacerbation.
Dr. Wong Soon Tee, 28 May 2020
Acne is a common skin problem seen in primary care. Dr Wong Soon Tee of Assurance Skin Clinic at Mt Elizabeth Novena Hospital, Singapore shares his insights with Pearl Toh on how to manage acne in the primary care setting.
27 May 2020
The perception that proton pump inhibitors (PPIs) cause multiple serious adverse effects (AEs) is supported by many internists, who then recommend treatment cessation even in patients at high risk for upper gastrointestinal bleeding (UGIB), reveals a study.

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
Roshini Claire Anthony, 6 days ago

For coffee drinkers, drinking filtered coffee may be tied to a lower mortality risk, including cardiovascular disease (CVD)-related mortality, a study from Norway suggested.

4 days ago
Use of corticosteroid is not associated with improved outcomes in idiopathic pulmonary fibrosis (IPF) patients admitted to the hospital with acute exacerbation (AE), reveals a recent study. In addition, corticosteroids may even contribute to reduced overall survival following exacerbation.
Dr. Wong Soon Tee, 28 May 2020
Acne is a common skin problem seen in primary care. Dr Wong Soon Tee of Assurance Skin Clinic at Mt Elizabeth Novena Hospital, Singapore shares his insights with Pearl Toh on how to manage acne in the primary care setting.
27 May 2020
The perception that proton pump inhibitors (PPIs) cause multiple serious adverse effects (AEs) is supported by many internists, who then recommend treatment cessation even in patients at high risk for upper gastrointestinal bleeding (UGIB), reveals a study.