Cipla receives final approval for Valganciclovir Tablets 450mg
Deepthi | Myequity news | Date : 12-11-2018 10:00:00 IST
Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for Valganciclovir Tablets 450mg from the United States Food and Drug Administration (US FDA).
Cipla’s Valganciclovir Tablets 450mg is AB-rated generic therapeutic equivalent version of Roche’s Valcyte®. It is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated for use in the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) and prevention of CMV disease in kidney, heart, and kidney- pancreas transplant patients at high risk.
According to IQVIA (IMS Health), Valcyte® and its generic equivalents had US sales of approximately $79M for the 12-month period ending September 2018. The product is available for shipping immediately.
Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics. It strengths in the respiratory, anti-retroviral, urology, cardiology and CNS segments are well-known. Its 44 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets.