Teva Gets Tentative Approval for Lansoprazole Delayed Release Tablets
January 25, 2008
Teva Pharmaceutical Industries has said that the FDA has granted tentative approval for the company’s abbreviated new drug application to market lansoprazole delayed-release capsules, 15mg and 30mg.
Lansoprazole delayed-release capsules are generic version of Tap Pharmaceutical’s gastric-acid pump inhibitor, Prevacid (lansoprazole) delayed-release capsules. According to IMS sales data, the brand product had annual sales of approximately $3.4 billion in the US for the 12 months ended September 30, 2007.