RECENT FDA APPROVALS

Drug Name Manufacturer

anacaulase-bcdb (Nexobrid®) Vericel albuterol/budesonide (Airsupra™)

AstraZeneca

Description

New Drugs

• BLA approval 12/28/2022; Orphan Drug

• Indicated for eschar removal in adults with deep partial thickness and/or full thickness thermal burns

• Safety and effectiveness have not been established for the treatment of the following: chemical or electrical burns; burns on the face, perineum, or genitalia; burns on the feet of patients with diabetes or occlusive vascular disease; circumferential burns; patients with significant cardiopulmonary disease, including inhalation injury; it is not recommended for wounds contaminated with radioactive or other hazardous substances

• Botanical drug product containing proteolytic enzymes

• Topical gel: 8.8%

• Recommended dosage is 1.94 g of anacaulase-bcdb in 2 g powder mixed with 20 g gel per 1% body surface area (BSA), or 4.85 g of anacaulase-bcdb in 5 g powder mixed with 50 g gel per 2.5% BSA; may be applied in up to 2 applications of 4 hours each; first application may be applied to an area of up to 15% BSA, second application may be applied 24 hours later for a total treated area for both applications not exceeding 20% BSA; product is only to be administered by an HCP; topical use only

• 505(b)(2) NDA approval 01/10/2023; Standard Review

• Indicated for as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma ≥ 18 years of age

• Beta2-adrenergic agonist (albuterol) and corticosteroid (budesonide) combination

• Inhalation aerosol: pressurized metered-dose inhaler that delivers a fixed-dose combination of albuterol 90 mcg and budesonide 80 mcg per actuation

• Recommended dosage is 180 mcg/160 mcg (administered as 2 actuations of albuterol/budesonide 90 mcg/80 mcg) by oral inhalation as needed for asthma symptoms; maximum of 6 doses (12 inhalations) in a 24-hour period