Sun Pharma yesterday announced that one of its wholly-owned subsidiaries has received final approval from the 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.
The company has been granted Competitive Generic Therapy (CGT) designation by the 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 annualised
sales of approximatel $136 million in the US.