Sun Pharma 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 USA.
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