Most Read Articles
Pearl Toh, Yesterday
The combination therapy comprising carfilzomib, cyclophosphamide and dexamethasone (KCd) is effective, with a tolerable safety profile, in an Asian cohort with high-risk multiple myeloma (MM) — thus providing a more economical alternative as a potential upfront regimen in resource-limited settings, according to leading experts during a myeloma education webinar.
Audrey Abella, 4 days ago
Extremes of sleep duration (≤5 or ≥10 hours/day), which is a known mortality risk factor in the general population, may increase absolute mortality in adults with type 2 diabetes (T2D), a prospective study has shown.
Pearl Toh, 21 Sep 2020
Early and sustained treatments with simplified regimen are the key to achieving good asthma control, said experts during a presentation at the ERS 2020 Congress.
Roshini Claire Anthony, 12 Oct 2020

Insulin icodec, an in-development basal insulin analogue administered once weekly, was as effective as once-daily insulin glargine in patients with type 2 diabetes (T2D) insufficiently controlled with metformin with or without a DPP-4* inhibitor, according to a phase II trial presented at EASD 2020.

Original New Drug Application Approvals by US FDA (16 - 30 June 2019)

02 Jul 2019
New drug applications approved by US FDA as of 16 - 30 June 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.

MYXREDLIN
  • Active Ingredient(s): Insulin human; sodium chloride
  • Strength:  100 mL; 9%
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Celerity Pharms
  • Approval Date: 20 June 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
  • Approved Label20 June 2019 (PDF)

VYLEESI
  • Active Ingredient(s): Bremelanotide acetate
  • Strength: 1.75 mg/0.3 mL
  • Dosage Form(s) / Route(s): Injectable; intravenous, subcutaneous
  • Company: Amag Pharms, Inc.
  • Approval Date: 21 June 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:
    • A co-existing medical or psychiatric condition,
    • Problems with the relationship, or
    • The effects of a medication or drug substance.
  • Approved Label21 June 2019 (PDF)

ZIRABEV
  • Active Ingredient(s): Bevacizumab-bvzr
  • Strength: 100 mg/4 mL; 400 mg/16 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Pfizer, Inc.
  • Approval Date: 27 June 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of:
    • Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.
    • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.
  • Approved Label27 June 2019 (PDF)

THIOLA EC
  • Active Ingredient(s): Tiopronin
  • Strength: 100 mg; 300 mg
  • Dosage Form(s) / Route(s): Tablet, delayed release; oral
  • Company: Mission Pharmacal Co.
  • Approval Date: 28 June 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Not available
  • Approved Label: Not available
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Most Read Articles
Pearl Toh, Yesterday
The combination therapy comprising carfilzomib, cyclophosphamide and dexamethasone (KCd) is effective, with a tolerable safety profile, in an Asian cohort with high-risk multiple myeloma (MM) — thus providing a more economical alternative as a potential upfront regimen in resource-limited settings, according to leading experts during a myeloma education webinar.
Audrey Abella, 4 days ago
Extremes of sleep duration (≤5 or ≥10 hours/day), which is a known mortality risk factor in the general population, may increase absolute mortality in adults with type 2 diabetes (T2D), a prospective study has shown.
Pearl Toh, 21 Sep 2020
Early and sustained treatments with simplified regimen are the key to achieving good asthma control, said experts during a presentation at the ERS 2020 Congress.
Roshini Claire Anthony, 12 Oct 2020

Insulin icodec, an in-development basal insulin analogue administered once weekly, was as effective as once-daily insulin glargine in patients with type 2 diabetes (T2D) insufficiently controlled with metformin with or without a DPP-4* inhibitor, according to a phase II trial presented at EASD 2020.