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Lotus' ANDA of Paricalcitol capsules has been officially approved by US FDA

Business
25 February 2016

Lotus Pharmaceutical Co., Ltd (“Lotus” or “the Company”, Taiwan OTC stock code: 1795) today announced that it received the final approval for its ANDA(“Abbreviated New Drug Application”) of Paricalcitol Capsules 1 mcg, 2 mcg, and 4 mcg from US FDA. The Company will start the preparation to launch the product in the near future.

Paricalcitol is a Vitamin D analog indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease. The formulation and manufacturing of Paricalcitol are relatively difficult due to the dosage requirements and its being a high potency soft gel product, which at the same time requires dedicated production facilities with strict standards for manufacturing. Lotus has the capability of manufacturing the high potency soft gel products for the US market by itself backed by its superior production facilities in Nantou Taiwan which successfully passed its third FDA inspection recently.

For US market, Lotus has launched its Mefenamic Acid Capsule 250mg in 2014 and Levonorgestrel Tablet 1.5mg in 2015. It will continue to develop its export business to further enhance its overall competitive advantages.