Breckenridge announced that the FDA has granted final approval for the Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-Release Capsules, the generic version of Takeda‘s Prevacid.
Prevacid is a proton pump inhibitor indicated in triple therapy or dual therapy for H. pylori eradication in duodenal ulcer disease, short-term treatment of active duodenal ulcer, active benign gastric ulcer, erosive esophagitis (EE), symptomatic GERD, and NSAID-associated gastric ulcers when NSAID use is continued. It is also indicated to reduce risk of NSAID-associated gastric ulcer in patients with history of gastric ulcer who need an NSAID, for maintenance of healing of duodenal ulcer and EE, and for long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome).
Lansoprazole is available in 15mg and 30mg strength delayed-release capsules.
For more information call (646) 448-1300 or visit www.bpirx.com.