Lupin Receives FDA Tentative Approval For Selexipag, Launches Diazepam Rectal Gel In The U.S
Lupin received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Selexipag for Injection, 1800 mcg/vial, Single-Dose Vial, to market a generic equivalent of Uptravi for Injection, 1800 mcg/vial, of Actelion Pharmaceuticals US.
Lupin also launched Diazepam Rectal Gel, 10 mg and 20 mg, Rectal Delivery System, after its wholly owned subsidiary, Novel Laboratories, based in Somerset, New Jersey received approval for its ANDA from the United States Food and Drug Administration (U.S. FDA), the company informed in an exchange filing on Thursday.
Diazepam Rectal Gel, 10 mg and 20 mg, Rectal Delivery System is the generic version of Diastat AcuDialTM Rectal Delivery System, 10 mg and 20 mg, of Bausch Health US, LLC, the company stated. Diazepam Rectal Gel (RLD Diastat AcuDialTM) had estimated annual sales of USD 37 million in the U.S. (IQVIA MAT September 2023), the statement from the company read.
The company informed that the New Drug Application for Selexipag for Injection will be manufactured at Lupin’s Nagpur facility in India. The company further added that the product sales for Selexipag Franchise in the U.S. were USD 1,104 million for the year ending December 2022 and USD 978 million for the fiscal nine months ending October 1, 2023
