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

18 Feb 2020
Original New Drug Application Approvals by US FDA (01 - 15 February 2020)
New drug applications approved by US FDA as of 01 - 15 February 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.

PIZENSY
  • Active Ingredient(s): Lactitol monohydrate (BLI400)
  • Strength: 10 g; 20 g
  • Dosage Form(s) / Route(s): Solution; oral
  • Company: Braintree Labs
  • Approval Date: 12 February 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of chronic idiopathic constipation (CIC) in adults.
  • Approved Label: 12 February 2020 (PDF)

PEMFEXY
  • Active Ingredient(s): Pemetrexed
  • Strength: 25 mg/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Eagle Pharms
  • Approval Date: 08 February 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for:
    • in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic non-squamous, non-small cell lung cancer (NSCLC).
    • as a single agent for the maintenance treatment of patients with locally advanced or metastatic non-squamous NSCLC whose disease has not progresses after four cycles of platinum-based first-line chemotherapy.
    • as a single agent for the treatment of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy.
    • in combination with cisplatin for the initial treatment, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
  • Approved Label: 08 February 2020 (PDF)

TWIRLA
  • Active Ingredient(s): Levonorgestrel; ethinyl estradiol
  • Strength: 120 mcg; 30 mcg
  • Dosage Form(s) / Route(s): System; transdermal
  • Company: Agile Therapeutics, Inc.
  • Approval Date: 14 February 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated as a method of contraception for use in women of reproductive potential with a BMI <30 kg/m2 for whom a combined hormonal contraceptive is appropriate. 
  • Approved Label: 14 February 2020 (PDF)

PROCYSBI
  • Active Ingredient(s): Cysteamine bitartrate
  • Strength: 75 mg; 300 mg
  • Dosage Form(s) / Route(s): Granule, delayed release; oral
  • Company: Horizon Pharma USA
  • Approval Date: 14 February 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older.
  • Approved Label: 14 February 2020 (PDF)