In another development, Dr. Reddy’s Laboratories said it has introduced Regadenoson Injection 0.4 mg/5 mL, a generic therapeutic equivalent of Astellas US LLC’s Lexiscan (Regadenoson) injection, in the U.S. market.
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Dr. Reddy’s Laboratories has been issued a Form 483 with one observation by the United States Food and Drug Administration following an inspection of the company’s active pharmaceutical ingredient (API) manufacturing facility in Bollaram, Hyderabad.
It was a routine GMP inspection of the facility (CTO 1) conducted from May 1-5. “We have been issued a Form 483 with one observation, which we will address within the stipulated timeline,” Dr. Reddy’s said in an intimation to the stock exchange on Friday. The company’s shares closed 0.66% lower to Rs.4,936.90 each on the BSE.
Through Form 483, the U.S. FDA notifies the management of the company whose facility it inspected of objectionable conditions observed by its officials that may constitute violations of the Food Drug and Cosmetic Act and related Acts.
Unveils Lexiscan generic in U.S.
In another development, Dr. Reddy’s Laboratories said it has introduced Regadenoson Injection 0.4 mg/5 mL, a generic therapeutic equivalent of Astellas US LLC’s Lexiscan (Regadenoson) injection, in the U.S. market.
Dr. Reddys said the product has been launched following U.S. FDA approval and supplied as single-dose pre-filled syringes, 0.4 mg/5 mL (0.08 mg/mL). A pharmacologic stress agent, the injection is indicated for radionuclide myocardial perfusion imaging (MPI) in patients who are unable to undergo adequate exercise stress test to detect coronary artery disease (CAD).
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