Most Read Articles
Pearl Toh, 4 days ago
Every-two-month injections of the long-acting cabotegravir + rilpivirine were noninferior to once-monthly injections for virologic suppression at 48 weeks in people living with HIV*, according to the ATLAS-2M** study presented at CROI 2020 — thus providing a potential option with more convenient dosing.
Stephen Padilla, 19 Mar 2020
The assumption that children are less vulnerable to the coronavirus disease 2019 (COVID-19) compared to adults is not quite true and may even be dangerous, suggests a recent study.
22 Mar 2020
Sustained use of lopinavir-combined regimen appears to confer benefits among patients with the novel coronavirus disease (COVID-19), with improvement possibly indicated by increasing eosinophils, suggests a recent study.
24 Mar 2020
COVID-19 is a novel disease, with no existing immunity. The virus can be transmitted from person to person, quickly and exponentially. Here’s what we can do to slow down the spread, if not contain the outbreak.

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, 4 days ago
Every-two-month injections of the long-acting cabotegravir + rilpivirine were noninferior to once-monthly injections for virologic suppression at 48 weeks in people living with HIV*, according to the ATLAS-2M** study presented at CROI 2020 — thus providing a potential option with more convenient dosing.
Stephen Padilla, 19 Mar 2020
The assumption that children are less vulnerable to the coronavirus disease 2019 (COVID-19) compared to adults is not quite true and may even be dangerous, suggests a recent study.
22 Mar 2020
Sustained use of lopinavir-combined regimen appears to confer benefits among patients with the novel coronavirus disease (COVID-19), with improvement possibly indicated by increasing eosinophils, suggests a recent study.
24 Mar 2020
COVID-19 is a novel disease, with no existing immunity. The virus can be transmitted from person to person, quickly and exponentially. Here’s what we can do to slow down the spread, if not contain the outbreak.