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

17 Mar 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 Label02 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 Label04 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 Label06 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 Label09 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 Label13 March 2020 (PDF)
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Most Read Articles
01 Dec 2020
Tetanus toxoid 5 Lf, diphtheria toxoid 2 Lf, pertussis toxoid 2.5 mcg, filamentous haemagglutinin 5 mcg, fimbriae types 2 and 3 5 mcg, pertactin 3 mcg
Stephen Padilla, 31 Jan 2020
The combination of ivermectin 1% cream (IVM) and doxycycline 40-mg modified-release capsules (DMR) delivers faster responses, better response rates and greater satisfaction compared with monotherapy in patients with severe rosacea, a recent study has shown.
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