Zydus Cadila has received the final approval from the USFDA to market Albendazole Tablets USP (US RLD – ALBENZA® tablets), 200 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. This medication is used to treat certain tapeworm infections (such as neurocysticercosis and hydatid disease). The group also received a tentative approval for Pregabalin Capsules (US RLD – Lyrica) in the strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. Pregabalin is used to help control certain kinds of seizures, painful nerve diseases and fibromyalgia. The group now has 239 approvals and has so far filed over 340 ANDAs since the commencement of the filing process in FY 2003-04
Liva Pharmaceuticals receives approval from the USFDA for its supplemental abbreviated new drug application (sANDA), Ranitidine Injection USP
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.