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

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

SARCLISA

• Active Ingredient(s): Isatuximab-irfc
• Strength: 100 mg/5 mL (20 mg/mL); 500 mg/25 mL (20 mg/mL)
• Dosage Form(s) / Route(s): Injectable; injection
• Company: Sanofi Aventis US
• Approval Date: 02 March 2020
• Submission Classification: Not available
• Indication(s): Indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
• Approved Label: 02 March 2020 (PDF)

DURYSTA

• Active Ingredient(s): Bimatoprost
• Strength: 10 mcg
• Dosage Form(s) / Route(s): Implant; implantation
• Company: Allergan
• Approval Date: 04 March 2020 
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
• Approved Label: 04 March 2020 (PDF)

ISTURISA

• Active Ingredient(s): Osilodrostat
• Strength: 1 mg; 5 mg; 10 mg
• Dosage Form(s) / Route(s): Tablet; oral
• Company: Novartis Pharms Corp
• Approval Date: 06 March 2020
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.
• Approved Label: 06 March 2020 (PDF)

FLUORESCEIN SODIUM; BENOXINATE HYDROCHLORIDE

• Active Ingredient(s): Fluorescein sodium; benoxinate hydrochloride
• Strength: 0.3%; 0.4%
• Dosage Form(s) / Route(s): Solution; ophthalmic
• Company: Baush Health Ireland, Ltd.
• Approval Date: 09 March 2020
• Submission Classification: Type 4 - New Combination
• Indication(s): Indicated for procedures in adult and pediatric patients requiring a disclosing agent in combination with topical ophthalmic anesthetic.
• Approved Label: 09 March 2020 (PDF)

ROMIDEPSIN

• Active Ingredient(s): Romidepsin
• Strength: 10 mg/2 mL; 27.5 mg/5.5 mL
• Dosage Form(s) / Route(s): Injectable; injection
• Company: Teva Pharms USA, Inc.
• Approval Date: 13 March 2020
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for: 
  • Treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy.
  • Treatment of peripheral T-cell lymphoma (PTCL) in adult patients who have received at least one prior therapy. 
• Approved Label: 13 March 2020 (PDF)