FDA approves Aurobindo’s generic Zemplar

DAYTON, N.J. — The Food and Drug Administration has approved Aurobindo Pharma’s generic Zemplar (paricalcitol) tablets, the company announced Thursday. The drug is indicated to treat and prevent secondary hyperparathyroidism in patients with stage 3, 4 and 5 chronic kidney disease, as well as stage 5 patients on dialysis. 

 

The drug will be available in 1-, 2- and 4-mcg dosage strengths. The drug had sales of $38.5 million for the 12 months ended November 2015, according to IMS Health.