Liva Pharmaceuticals Receives Approval from the USFDA for its sANDA, Ranitidine Injection

Liva Pharmaceuticals Limited, a wholly-owned subsidiary company of Cadila Healthcare Limited has received the approval from the USFDA for its supplemental abbreviated new drug application (sANDA), Ranitidine Injection USP, 25 mg/mL, 2 mL Single dose vials and 6 mL Multi-dose vials. It will be manufactured at Liva Pharma’s manufacturing facility at Vadodara and is the first product to be approved from this site for marketing in the US. Ranitidine belongs to the class of medications called H2-antagonists and is used to treat stomach and duodenal (intestinal) ulcers, and prevent them from recurring. It is also used to treat gastroesophageal reflux disease (GERD) and Zollinger-Ellison Syndrome. The injectable form of ranitidine is given for short-term treatment of these conditions when a patient is unable to take this medication orally. The group now has 237 approvals and has so far filed over 340 ANDAs since the commencement of the filing process in FY 2003-04. – Medical Buyer Bureau