Original New Drug Application Approvals by US FDA (16 - 31 July 2020)

New drug applications approved by US FDA as of 16 - 31 July 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.

CARBON DIOXIDE, USP

• Active Ingredient(s): Carbon dioxide
• Strength: Not available
• Dosage Form(s) / Route(s): Gas; inhalation
• Company: Nexair LLC
• Approval Date: 18 July 2020
• Submission Classification: Not available
• Indication(s): Not available
• Approved Label: Not available

WYNZORA

• Active Ingredient(s): Calcipotriene/betamethasone dipropionate
• Strength: 0.005%/0.064%
• Dosage Form(s) / Route(s): Cream; topical
• Company: MC2 Therapeutics, Inc.
• Approval Date: 20 July 2020
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.
• Approved Label: 20 July 2020 (PDF)

XYWAV

• Active Ingredient(s): Calcium; magnesium; potassium; sodium oxybates
• Strength: 0.5 mg/mL
• Dosage Form(s) / Route(s): Solution; oral
• Company: Jazz Pharms, Inc.
• Approval Date: 21 July 2020
• Submission Classification: Not available
• Indication(s): Indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
• Approved Label: 21 July 2020 (PDF)

BREZTRI AEROSPHERE

• Active Ingredient(s): Budesonide; formoterol fumarate; glycopyrrolate
• Strength: 160 mcg/inh; 4.8 mcg/inh; 9 mcg/inh
• Dosage Form(s) / Route(s): Aerosol, metered; inhalation
• Company: Astrazeneca AB
• Approval Date: 23 July 2020
• Submission Classification: Not available
• Indication(s): Indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
• Approved Label: 23 July 2020 (PDF)

XEGLYZE

• Active Ingredient(s): Abametapir
• Strength: 0.74%
• Dosage Form(s) / Route(s): Lotion; topical
• Company: Dr Reddys Labs SA
• Approval Date: 24 July 2020
• Submission Classification: Type 1 - New Molecular Entity
• Indication(s): Indicated for the topical treatment of head lice infestation in patients 6 months of age and older. Xeglyze should be used in context of an overall lice management program:
• Wash (with hot water) or dry-clean all recently worn clothing, hats, used bedding and towels
• Wash personal care items such as combs, brushes and hair clips in hot water
• Use a fine-tooth comb or special nit comb to remove dead lice and nits
• Approved Label: 24 July 2020 (PDF)

CYCLOPHOSPHAMIDE

• Active Ingredient(s): Cyclophosphamide
• Strength: 500 mg/2.5 mL; 1 g/5 mL
• Dosage Form(s) / Route(s): Injectable; injection
• Company: Ingenus Pharms, LLC
• Approval Date: 30 July 2020
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated for treatment of:
• Malignant Diseases: malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma.
• Approved Label: 30 July 2020 (PDF)

MONJUVI (TAFASITAMAB-CXIX) FOR INJECTION

• Active Ingredient(s): Tafasitamab-cxix
• Strength: 12 mg/kg
• Dosage Form(s) / Route(s): Injectable; injection
• Company: Morphosys US, Inc.
• Approval Date: 31 July 2020
• Submission Classification: Not available
• Indication(s): Indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).
• Approved Label: 31 July 2020 (PDF)