RECENT FDA APPROVALS

Drug Name Manufacturer

sotagliflozin (Inpefa™)

Lexicon cyclosporine (Vevye™)

Novaliq respiratory syncytial virus vaccine (Abrysvo™) Pfizer glofitamab-gxbm (Columvi™) Genentech

Description

New Drugs

• NDA approval 05/26/2023; Standard Review

• Indicated for adults with HF or T2DM, CKD, and other CV risk factors to reduce the risk of CV death, hospitalization for HF, and urgent HF visit

• Sodium-glucose cotransporter (SGLT) 1 and SGLT2 inhibitor

• Oral tablet: 200 mg, 400 mg

• Recommended initial dosage is 200 mg orally once daily not > 1 hour before the first meal of the day, titrated after ≥ 2 weeks to 400 mg once daily

• Product availability is expected by the end of June 2023

• 505(b)(2) NDA approval 05/30/2023; Standard Review

• Indicated to treat the signs and symptoms of dry eye disease in adults

• Calcineurin inhibitor immunosuppressant

• Preservative-free ophthalmic solution: 0.1%

• Recommended dosage is 1 drop in each eye twice daily approximately 12 hours apart and separated from other eye drops by a 15-minute interval

• BLA approval 05/31/2023; Breakthrough Therapy, Priority Review

• Indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults ≥ 60 years of age

• Recombinant protein vaccine

• Lyophilized antigen component requires dilution with accompanying sterile water diluent in a prefilled syringe

• Recommended dosage is a single 0.5 mL IM dose

• Product availability is expected by Q3 2023

• BLA approval 06/15/2023; Accelerated Approval, Fast Track, Priority Review

• Indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after ≥ 2 lines of systemic therapy; continued approval for this use may require demonstration of benefit in confirmatory clinical trials

• Bispecific CD20-directed CD3 T-cell engager

• Single-dose vial: 2.5 mg/2.5 mL, 10 mg/10 mL

• HCP-administered IV infusion with step-up dosing on days 8 and 15 of cycle 1 (following day 1 pretreatment with obinutuzumab [Gazyva®]), then administered on day 1 of subsequent 21-day cycles for a maximum of 12 cycles or until disease progression or unacceptable toxicity

• Labeled with a boxed warning related to the risk of cytokine release syndrome

• Product availability is expected in Q3 2023