Cipla Ltd, a global pharmaceutical company has announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Decitabine Injection 50 mg single-use sterile vial from the United States Food and Drug Administration (US FDA) to market generic version of Otsuka America Pharmaceutical Inc.’s Dacogen.
Cipla’s Decitabine Injection 50 mg/vial is AP-rated and is generic equivalent of Otsuka America Pharmaceutical Inc.’s, Dacogen®. It is indicated for treatment of patients with myelodysplastic syndromes (MDS). The product is available for shipping immediately. Dacogen® and its generic equivalents had U.S. sales of approximately $180M for the 12-month period ending September 2017, as reported by IMS Health.
About Cipla Ltd. About Cipla Ltd. Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. In the last 80+ years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 80 countries. Our portfolio includes over 1500 products across wide range of therapeutic categories with one quality standard globally.
Whilst delivering a long-term sustainable business, Cipla recognises its duty to provide affordable medicines. Cipla’s emphasis on access for patients was recognised globally for the pioneering role played in HIV/AIDS treatment as the first pharmaceutical company to provide a triple combination anti-retroviral (ARV) in Africa at less than a dollar a day and thereby treating many millions of patients since 2001. Cipla’s research and development focuses on developing innovative products and drug delivery systems.