Written By: Pharmacally Medical News Desk
Amneal Pharmaceuticals announced U.S. FDA approvals for two key generic formulations in early December 2025: albuterol sulfate inhalation aerosol on December 2 and cyclosporine ophthalmic emulsion 0.05% on December 1. These approvals target high-demand markets in respiratory and ophthalmic treatments, with combined U.S. sales exceeding $3.5 billion for the referenced products over the 12 months ending September 2025.
Albuterol Sulfate Inhalation Aerosol Details
The albuterol sulfate inhalation aerosol (90 mcg per actuation) is a generic equivalent of PROAIR HFA, indicated for treating or preventing bronchospasm in adults and children 12 years and older with reversible obstructive airway disease. Common adverse reactions include headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis. This approval builds on Amneal’s recent beclomethasone dipropionate inhalation aerosol, strengthening its respiratory portfolio amid ongoing supply concerns for inhaled therapies.
Cyclosporine Ophthalmic Emulsion Details
Cyclosporine ophthalmic emulsion 0.05%, in sterile preservative-free single-use vials, is the generic version of RESTASIS and increases tear production in patients with dry eye disease linked to ocular inflammation. The most common side effect is ocular burning, with no increased tear production observed in those using topical anti-inflammatories or punctal plugs. Launch is planned for Q1 2026, highlighting Amneal’s expertise in complex sterile manufacturing.
Strategic Impact
Dr. Srinivas Kone, Amneal’s Senior VP and Chief Scientific Officer for Affordable Medicines, emphasized these as milestones in complex formulations across inhalation, injectable, and ophthalmology. With IQVIA reporting $1.5 billion in albuterol sales and $2.0 billion for cyclosporine, these generics promise enhanced affordability for asthma/COPD and dry eye patients. Amneal continues expanding its Affordable Medicines segment through advanced drug delivery innovations.
References
Amneal Receives U.S. FDA Approval for Albuterol Sulfate Inhalation Aerosol, Amneal, 02 December 2025, Amneal, https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Receives-U-S–FDA-Approval-for-Albuterol-Sulfate-Inhalation-Aerosol/default.aspx
Amneal Announces U.S. FDA Approval of Cyclosporine Ophthalmic Emulsion 0.05%, 01 December 2025, Amneal, https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Announces-U-S–FDA-Approval-of-Cyclosporine-Ophthalmic-Emulsion-0-05/default.aspx