By: IPP Bureau
Last updated : December 16, 2021 10:50 am
It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity
Sun Pharmaceuticals announced that one of its wholly-owned subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic Amphotericin B Liposome for Injection, 50 mg/vial Single-Dose Vial. The generic product approval is based on AmBisome Liposome for Injection, 50 mg/vial as a reference product.
Sun Pharma has been granted Competitive Generic Therapy (CGT) designation by US FDA and being the first approved generic, is eligible for 180 days of CGT exclusivity for the product.
As per October 2021 IQVIA Health data, AmBisome Liposome for Injection, 50mg/vial had annualized sales of approximately US$ 136 million in the USA.