HORIZON LINES: A QUARTERLY REVIEW OF NDAs Approval Date 01/05/2024 Drug Name Zelsuvmi 01/18/2024 Dolutegravir; Emtricitabine; Tenofovir Alafenamide 02/09/2024 Eohilia Active Ingredients Berdazimer Sodium Submission Classification* Type 1 Company LNHC, Inc. Type Of Dosage/ Route Gel; Topical Comments First novel drug for the treatment of molluscum contagiosum Dolutegravir; Emtricitabine; Tenofovir Alafenamide Type 4 Hetero Labs Ltd. Tablet; Oral Used for the treatment of human immunodeficiency virus type 1 (HIV-1) infection Budesonide Type 3 02/13/2024 Legubeti 02/13/2024 Aurlumyn 02/14/2024 Pantoprazole Sodium In 0.9% Sodium Chloride 02/16/2024 Sehippy 02/17/2024 Carbon Dioxide Acetylcysteine Lysine Iloprost Type 2 and Type 3 Type 3 Takeda Pharmaceutical Company Galephar Eicos Sciences Suspension; Oral For Solution; Oral Solution; Intravenous Pantoprazole Sodium Type 3 Vortioxetine Type 2 and Type 3 Carbon Dioxide 02/22/2024 Exblifep 02/23/2024 Simlandi Cefepime Hydrochloride; Enmetazobactam Adalimumab-Ryvk 02/29/2024 Letybo Letibotulinumtoxina-Wlbg Type 5 Type 1 and Type 4 BLA Baxter Healthcare Corp. Solution; Intravenous Seasons Biotech Co. Ltd. Haun Specialty Gases Inc. Allecra Therapeutics Alvotech USA Inc. Tablet; Orally Disintegrating Gas; Inhalation Powder; Intravenous Injectable; Injection BLA Hugel Inc. Powder; Solution 03/04/2024 Clobetasol Propionate Clobetasol Propionate Type 5 Formosa Pharmaceuticals Suspension/ Drops; Ophthalmic Injectable; 03/05/2024 Tyenne Tocilizumab-Aazg BLA Fresenius Kabi USA Subcutaneous; Intravenous 03/05/2024 Jubbonti Denosumab-Bbdz BLA Sandoz Inc. Injectable; Subcutaneous Pharmaceutical Outsourcing | 36 | April/May/June 2024 The first and only FDA- approved oral treatment for eosinophilic esophagitis (EoE) It is an antidote for acetaminophen overdose. To treat severe frostbite in adults to reduce the risk of digit amputations. Short-term treatment for adults with GERD and a history of erosive esophagitis. It is used to treat major depressive disorder. Used to enlarge and stabilize the body cavity for greater visibility and access to surgical areas. Treatment of urinary tract infections. received five-year exclusivity extension through GAIN Act. The first high-concentration and citrate-free biosimilar interchangeable with Humira. Treatment of glabellar lines. The first new steroid in over 15 years on the ophthalmic market. Biosimilar to Actemra used for different types of arthritis An interchangeable biosimilar to U.S.-licensed Prolia (denosumab)