Amneal Pharmaceuticals Inc. Class A (NASDAQ:AMRX) traded higher in premarket activity on Thursday after receiving U.S. Food and Drug Administration approval for its romidepsin injection solution, a treatment used in certain lymphoma patients.
Shares of the company gained 2.5% following the announcement.
FDA Approves Ready-to-Use Romidepsin Injection
The FDA approved Amneal’s romidepsin injection solution, 27.5 mg/5.5 mL, which will be supplied in single-dose, ready-to-use vials.
The product has been granted Competitive Generic Therapy (CGT) status, providing the company with 180 days of market exclusivity.
Amneal said the approval strengthens its oncology portfolio while offering healthcare providers a more convenient formulation compared with products that require reconstitution before administration.
Alternative to Existing Formulations
The newly approved product serves as an alternative to lyophilized romidepsin powder formulations that must be mixed prior to use.
Amneal’s injection solution references a romidepsin solution previously marketed by Teva, which was withdrawn from the market several years ago.
By introducing a ready-to-use option, the company aims to simplify preparation and administration for healthcare professionals.
Addresses a Market With Established Demand
According to IQVIA data cited by the company, U.S. sales of romidepsin lyophilized powder products totaled approximately $78 million during the 12 months ended April 2026.
The approval gives Amneal an opportunity to compete in an established market while benefiting from its period of exclusivity under the CGT programme.
Treatment Targets Cutaneous T-Cell Lymphoma
Romidepsin injection solution is classified as a histone deacetylase inhibitor and is indicated for the treatment of cutaneous T-cell lymphoma in adult patients who have previously received at least one systemic therapy.
The therapy is designed for patients whose disease has progressed or requires additional treatment following earlier interventions.
Safety Profile and Common Side Effects
The most frequently reported adverse reactions associated with romidepsin injection solution include nausea, fatigue, infections, vomiting, decreased appetite, electrocardiogram ST-T wave changes, altered taste perception, constipation and itching.
The company noted that significant laboratory abnormalities may include lymphopenia, neutropenia, anemia and thrombocytopenia.
Expanding Leadership in Competitive Generic Therapies
Amneal highlighted its track record in the Competitive Generic Therapy programme, stating that it has received more CGT approvals than any other company since the FDA began tracking the designation in 2018.
Management believes the latest approval further reinforces its position within the U.S. generic pharmaceutical market while supporting continued expansion of its specialty and oncology product offerings.