Lupin closed 2016 with 3 tentative generic approvals

SILVER SPRING, Md. — The Food and Drug Administration handed out three tentative generic approvals to Lupin in the last week of 2016, the company announced. The company received tentative approval for its generics of Benicar (olemsartan medoximil) tablets), Giazo (balasalazide disodium) tablets and Livalo (pitavastatin) tablets. 

 

The company’s generic of Daiichi Sankyo’s Benicar, which is indicated to treat hypertension, will be available in 20- and 40-mg dosage strengths. The drug had U.S. sales of $1.06 billion for the 12 months ended September 2016, according to QuintilesIMS data. 

 

The Giazo generic will be available in 1.1-gram tablets, and the drug, for the treatment of mildly to moderately active ulcerative colitis in men aged 18 years and older, had U.S. sales of 0.79 million for the 12 months ended September 2016, according to QuintilesIMS data. 

 

The company’s generic of Kowa’s Livalo tablets will be available in 1-. 2- and 4-mg dosage strengths. The drug is indicated to help lower total and LDL cholesterol while increasing HDL cholesterol and had U.S. sales of $245.3 million for the 12 months ended September 2016.