Santarus submits NDA for new Zegerid tablet

US drugmaker Santarus has submitted a New Drug Application to the Food and Drug Administration for a new tablet formulation to add to its  Zegerid (omeprazole/sodium bicarbonate) family of branded prescription  drugs. The new formulation is an immediate-release tablet that  combines omeprazole, a proton pump inhibitor, with a mix of buffers. The  company's objective is to have the new product commercially available in  the USA in the fourth quarter of 2009.

The NDA was submitted under section 505(b)(2) of the Federal Food, Drug,  and Cosmetic Act. If the NDA is accepted for filing by the FDA, Santarus  will provide notice to the NDA holder for Prilosec (delayed-release  omeprazole capsules) and related patent holders that the new tablet  formulation does not infringe the patents listed in the Orange Book for  Prilosec or that those patents are invalid.

Zegerid is indicated for the treatment of heartburn and other symptoms  associated with gastroesophageal reflux disease, maintenance of healing  and short-term treatment of erosive esophagitis, and short-term  treatment of active benign gastric ulcers and active duodenal ulcers.