Original New Drug Application Approvals by US FDA (16 - 30 June 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 Label: 20 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 Label: 21 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 Label: 27 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