USFDA Approvals

Link - https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&Appl_No=218054#44849

The U.S. Food and Drug Administration ("FDA") has approved the Company's Abbreviated New Drug Application ("ANDA") for Regadenoson injection, 0.4MG/5ML (0.08MG/ML) Single Dose PFS (Pre-Filled Syringe). Regadenoson is indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. The FDA determined that INDIES PHARMA JAMAICA LIMITED'S regadenoson is bioequivalent and therapeutically equivalent to Astellas Pharma U.S., Inc's Lexiscan® (Regadenoson Injection).

The correspondence dated 22nd Aug 2024 from the USFDA to INDIES stated:

This letter is in reference to your abbreviated new drug application (ANDA) received for review on January 25, 2023, submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Prefilled Syringe.

Your product is a combination product as defined by 21 CFR 3.2(e) and is comprised of drug and device constituent parts.

Reference is also made to the complete response letter issued by this office on November 22, 2023, and to any amendments thereafter:

• We have completed the review of this ANDA and have concluded that adequate information has been presented to demonstrate that the drug meets the requirements for approval under the FD&C Act.
• Accordingly, the ANDA is approved, effective on the date of this letter. We have determined your Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Prefilled Syringe to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Lexiscan Injection, 0.4 mg/5 mL (0.08 mg/mL) of Astellas Pharma US, Inc. (Astellas).
• The RLD upon which you have based your ANDA, Astellas’s Lexiscan Injection, 0.4 mg/5 mL (0.08 mg/mL), is subject to periods of patent protection. The following patents and expiration dates are currently listed in the Agency’s publication titled Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”):

U.S. Patent Number: 8,106,183 (the '183 patent), Expiration Date:February 2, 2027
U.S. Patent Number: RE47,301 (the '301 patent), Expiration Date:February 2, 2027

Your ANDA contains paragraph IV certifications to each of the patents under section 505(j)(2)(A)(vii)(IV) of the FD&C Act stating that the patents are invalid, unenforceable, or will not be infringed by your manufacture, use, or sale of Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Prefilled Syringe under this ANDA.

You have notified the Agency that Indies Pharma Jamaica Limited (Indies) complied with the requirements of section 505(j)(2)(B) of the FD&C Act and that no action for infringement was brought against Infill within the statutory 45-day period.