Original New Drug Application Approvals by US FDA (16 - 31 December 2019)

03 Jan 2020
Original New Drug Application Approvals by US FDA (16 - 31 December 2019)
New drug applications approved by US FDA as of 16 - 31 December 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.

ARALZO
  • Active Ingredient(s): Tazarotene
  • Strength: 0.045%
  • Dosage Form(s) / Route(s): Lotion; topical
  • Company: Dow Pharm
  • Approval Date: 18 December 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for the topical treatment of acne vulgaris in patient 9 years of age and older.
  • Approved Label: 18 December 2019 (PDF)

PADCEV
  • Active Ingredient(s): Enfortumab vedotin-ejfv
  • Strength: 20 mg/vial; 30 mg/vial
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Astellas
  • Approval Date: 18 December 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.
  • Approved Label: 18 December 2019 (PDF)

CONJUPRI
  • Active Ingredient(s): Levamlodipine
  • Strength: 1.25 mg; 2.5 mg; 5 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: CSPC Ouyi Pharma Co., Ltd.
  • Approval Date: 19 December 2019
  • Submission Classification: Type 2 - New Active Ingredient and Type 3 - New Dosage Form
  • Indication(s): May be used alone or in combination with other antihypertensive agents for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
  • Approved Label: 19 December 2019 (PDF)

TISSUEBLUE
  • Active Ingredient(s): Brilliant blue g
  • Strength: 0.025%
  • Dosage Form(s) / Route(s): Solution; ophthalmic
  • Company: Dutch Ophthalmic Research
  • Approval Date: 20 December 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated to selectively stain the internal limiting membrane (ILM).
  • Approved Label: 20 December 2019 (PDF)

ENHERTU
  • Active Ingredient(s): Fam-trastuzumab deruxtecan-nxki
  • Strength: 100 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Daiichi Sankyo
  • Approval Date: 20 December 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.
  • Approved Label: 20 December 2019 (PDF)

GENOSYL
  • Active Ingredient(s): Nitric oxide
  • Strength: 20 ppm
  • Dosage Form(s) / Route(s): Gas; inhalation
  • Company: Vero Biotech
  • Approval Date: 20 December 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
  • Approved Label: 20 December 2019 (PDF)

CAPLYTA
  • Active Ingredient(s): Lumateperone
  • Strength: 42 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Intra-cellular Therapies, Inc.
  • Approval Date: 20 December 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of schizophrenia in adults.
  • Approved Label: 20 December 2019 (PDF)

DAYVIGO
  • Active Ingredient(s): Lemborexant
  • Strength: 5 mg; 10 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Eisai, Inc.
  • Approval Date: 20 December 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.
  • Approved Label: 20 December 2019 (PDF)

UBRELVY
  • Active Ingredient(s): Ubrogepant
  • Strength: 10 mg; 50 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Allergan
  • Approval Date: 23 December 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the acute treatment of migraine with or without aura in adults.
  • Approved Label: 23 December 2019 (PDF)