Dr Reddy's Laboratories Ltd. announced on Friday the launch of Regadenoson injection, used as an agent in the imaging of heart muscle to check blood flow, in the U.S. market.
Regadenoson injection is supplied as single-dose pre-filled syringes, 0.4 mg/5 ml (0.08 mg/ml). It is a generic therapeutic equivalent of Lexiscan injection, approved by the U.S. Food and Drug Administration (USFDA), Dr Reddy's said in a regulatory filing.
The injection is a pharmacologic stress agent for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.
In a separate filing, Dr Reddy's said it has issued a Form 483 with one observation by the U.S. FDA after a routine GMP inspection at its API manufacturing facility (CTO 1) in Bollaram, Hyderabad.
"The inspection was conducted from May 1, 2023, to May 5, 2023. We have been issued a Form 483 with one observation, which we will address within the stipulated timeline", the company said.
As per the U.S. FDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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