June 14, 2023
Indies Pharma Jamaica Limited (INDIES) has advised that its ANDA (abbreviated new drug application) for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), dated January 25, 2023, was submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) at the U.S. Food & Drug Administration (“FDA”). The Company has received an Agency’s letter titled ‘PARAGRAPH IV ACKNOWLEDGEMENT ANDA RECEIPT” dated February 28, 2023. INDIES has also advised that on June 13, 2023, it submitted the patent amendment and notified the FDS that the stipulated statutory 45-day period after receipt of notice letter has passed, and no challenge has been filed against the Company by the original patent holder of NDA (new drug application) N022161 noted on the records of the U.S. Food & Drug Administration (“FDA”).
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