On 21-May2026, Rubicon Research Limited has received approval from the U.S. Food and Drug Administration (USFDA) for its Clonazepam Tablets USP through the Abbreviated New Drug Application (ANDA) pathway under application number 216988. The approval further strengthens the company’s presence in the U.S. generic pharmaceutical market and reflects its continued focus on expanding its product portfolio.
The approved product includes Clonazepam Orally Disintegrating Tablets (ODT) in strengths of 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 2 mg. The products carry a Therapeutic Equivalence (TE) code: AB, indicating therapeutic equivalence to the reference listed drug and supporting greater access to cost-effective treatment options in the U.S. market.
Clonazepam is a benzodiazepine medication commonly used for the management of certain seizure disorders and panic disorder. Generic drug approvals play an important role in increasing patient access to affordable treatment options while maintaining quality, safety, and therapeutic equivalence standards established by the USFDA.
This latest regulatory milestone highlights ongoing activity in the generic pharmaceutical space and demonstrates continued efforts by manufacturers to strengthen healthcare accessibility through approved alternatives.
REFERENCE: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216988