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

New drug applications approved by US FDA as of 01 - 15 December 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.

GALLIUM GA 68 PSMA-11

• Active Ingredient(s): PSMA-11 Ga 68
• Strength: 18.5 MBq/mL to 185 MBq/mL (0.5 mCi/mL to 5 mCi/mL)
• Dosage Form(s) / Route(s): Injectable; injection
• Company: University of California, Los Angeles
• Approval Date: 01 December 2020
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:
• with suspected metastasis who are candidates for initial definitive therapy.
• with suspected recurrence based on elevated serum prostate-specific antigen.
• Approved Label: 01 December 2020 (PDF)

HETLIOZ

• Active Ingredient(s): Tasimelteon
• Strength: 20 mg
• Dosage Form(s) / Route(s): Capsule; oral
• Company: Vanda Pharmaceuticals, Inc.
• Approval Date: 01 December 2020
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for the treatment of:
• Non-24-Hour Sleep-Wake Disorder (Non-24) in adults
• Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older.
• Approved Label: 01 December 2020 (PDF)

HETLIOZ LQ

• Active Ingredient(s): Tasimelteon
• Strength: 4 mg/mL
• Dosage Form(s) / Route(s): Suspension; oral
• Company: Vanda Pharmaceuticals, Inc.
• Approval Date: 01 December 2020
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for the treatment of:
• Non-24-Hour Sleep-Wake Disorder (Non-24) in adults
• Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older
• Approved Label: 01 December 2020 (PDF)

GAVRETO

• Active Ingredient(s): Pralsetinib
• Strength: 100 mg
• Dosage Form(s) / Route(s): Capsule; oral
• Company: Blueprint Medicines
• Approval Date: 01 December 2020
• Submission Classification: Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval
• Indication(s): Indicated for treatment of:
• Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC).
• Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy.
• Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
• Approved Label: 01 December 2020 (PDF)

ORLADEYO

• Active Ingredient(s): Berotralstat
• Strength: 150 mg; 110 mg
• Dosage Form(s) / Route(s): Capsule; oral
• Company: Biocryst Pharmaceuticals, Inc.
• Approval Date: 03 December 2020
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
• Approved Label: 03 December 2020 (PDF)

KLISYRI

• Active Ingredient(s): Tirbanibulin
• Strength: 1%
• Dosage Form(s) / Route(s): Ointment; topical
• Company: Athenex, Inc.
• Approval Date: 14 December 2020
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the topical treatment of actinic keratosis of the face or scalp.
• Approved Label: 14 December 2020 (PDF)