Natco Pharma has received approval for its Abbreviated New Drug Application (ANDA) for Carfilzomib Vials ANDA (generic for KYPROLIS ), from the U. S.
Food and Drug Administration (USFDA).
The parties have received final approval for 10mg and 60mg strengths of the product and tentative approval for 30mg strength of the product. Based on the ANDA filing date NATCO believes that it is eligible for 180 days of sole generic marketing exclusivity for the 10mg strength and shared 180 days of generic marketing exclusivity for the 60mg strength of the product at the time of launch.
Powered by Capital Market - Live News
(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)
Dear Reader,
Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.
We, however, have a request.
As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.
Support quality journalism and subscribe to Business Standard.
Digital Editor
RECOMMENDED FOR YOU