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ロータスはパリカルシトール・カプセルに関して、ANDA(Abbreviated New Drug Application)の仮承認を、アメリカFDAから取得した

Posted on 24.7.2015

Lotus Pharmaceutical Co., Ltd (“Lotus” or “the Company”, Taiwan OTC stock code: 1795) today announced that it received a tentative approval for its ANDA(“Abbreviated New Drug Application”) of Paricalcitol Capsules 1 mcg, 2 mcg, and 4 mcg from US FDA. A final approval of this ANDA will be made effective once all the patents has expired in January 2016.

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.

For US market, Lotus has launched its Mefenamic Acid Capsule 250mg in September last year. In addition, it also received final approvals from US FDA for Levonorgestrel Tablet 1.5mg in June and has started the preparation of product launch accordingly.