Lupin receives FDA approval for seizures medication Diazepam Rectal Gel

Lupin announced that its subsidiary Novel Laboratories has received approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application for Diazepam Rectal Gel, 10 mg and 20 mg, Rectal Delivery System.

This product is a generic equivalent of Diastat AcuDial Rectal Delivery System, 10 mg and 20 mg, which is marketed by Bausch Health US, LLC.

Novel Laboratories is located in Somerset, New Jersey.

The approval from the US FDA allows Lupin to bring a generic version of Diazepam Rectal Gel to the market. The original product, Diastat AcuDial, is indicated for the treatment of certain types of seizures in patients who experience episodes of increased seizure activity, also known as cluster or acute repetitive seizures. Diazepam Rectal Gel offers a convenient and effective rectal delivery system for this medication.

According to data from IQVIA MAT Mar 2023, the reference listed drug Diastat AcuDial had estimated annual sales of approximately $34 million in the United States. With the approval of Lupin’s generic version, patients and healthcare providers will have access to a more affordable alternative while maintaining the same quality and efficacy.

Lupin is an India-based pharmaceutical company with a strong focus on developing and manufacturing generic and branded pharmaceuticals. The approval of Diazepam Rectal Gel represents another milestone in Lupin’s efforts to expand its portfolio and offer cost-effective treatment options to patients in the United States.