Sun Pharma gets USFDA nod for Generic Amphotericin B Liposome Injection
Mumbai: Sun Pharmaceutical Industries Limited has announced that one of its wholly-owned subsidiaries has received final approval from United States Food and Drug Administration (USFDA) 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," the company said in a release.
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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Sun Pharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra. The company manufacture and market a large basket of pharmaceutical formulations covering a broad spectrum of chronic and acute therapies. It includes generics, branded generics, specialty, complex or difficult to make technology-intensive products, over-the-counter (OTC), antiretrovirals (ARVs), Active Pharmaceutical Ingredients (APIs) and Intermediates.
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