CIPLA receives approval from US FDA

Cipla Limited today announced that it 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 $79 million for the 12-month period ending September 2018. The product is available for shipping immediately.   
   
Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics    with  strengths in the respiratory, anti-retroviral, urology, cardiology and CNS segments.   
   

The stock reacted positively to this news today and touched intrday high of Rs. 541.82. Today stock closed at Rs. 531.30 on the BSE. While the index closed 345 points down at 34813.