Last Updated on December 17, 2021 by The Health Master
New Delhi: Sun Pharmaceutical Industries Ltd on Wednesday said it has received final approval from the US health regulator for generic Amphotericin B Liposome injection used in treatment of fungal infections with 180 days of exclusivity.
The approval granted by the USFDA to one of the company’s wholly-owned subsidiaries of the abbreviated new drug application (ANDA) of generic Amphotericin B Liposome for injection, is for the strength of 50 mg/vial single-dose Vial, Sun Pharmaceutical Industries said in a regulatory filing.
“Sun Pharma has been granted competitive generic therapy (CGT) designation by the USFDA and, being the first approved generic, is eligible for 180 days of CGT exclusivity for the product,” it added.
As per the USFDA (US Food and Drug Administration), the regulator may designate a drug as a CGT after determining that there is inadequate generic competition for that drug and there is not more than one approved drug included in its active approved list.
On successful application of CGT, the applicant gets a 180-day period of exclusivity, during which approval of certain subsequent ANDAs is not granted.
Sun Pharma added that the generic product approval is based on the AmBisome Liposome for Injection, 50 mg/vial, as a reference product.
Citing October 2021 IQVIA Health data, the company said AmBisome Liposome for injection, 50mg/vial, had annualised sales of approximately USD 136 million in the USA.
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