Shots:

• The approval is based on two P-III study results assessing Talicia vs active comparator arm and resulted in eradication of H. pylori infection (84% vs 58%)- response rate @13 day (90.3% vs 64.7%)- No resistance to rifabutin
• Talicia has market exclusivity of 8 years in the US under QIDP designation in addition to patent protection extending until 2034
• Talicia is a combination of two antibiotics amoxicillin and rifabutin and a PPI (omeprazole magnesium) is a delayed-release capsules 10 mg1/250 mg/12.5 mg with fixed-dose approved in the US for H. pylori infection in adults- with expected launch in Q1’20

Click here to­ read full press release/ article | Ref: GlobeNewswire | Image: Twitter