Submit Animal Toxicity Data: CDSCO panel Tells Dr. Reddy's on Ferric carboxymaltose injection
New Delhi: In response to the drug major Dr. Reddy's Laboratories' proposal to manufacture and market the Ferric Carboxymaltose Injection, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined that the firm should submit animal toxicity data as per New Drugs and Clinical Trial Rules 2019.
Ferric carboxymaltose injection is in a class of medications called iron replacement products. Ferric carboxymaltose injection is used to treat iron-deficiency anemia (a lower-than-normal number of red blood cells due to too little iron) in adults who cannot tolerate or who could not successfully be treated with iron supplements taken by mouth.
Ferric carboxymaltose injection is in a class of medications called iron replacement products. It works by replenishing iron stores so that the body can make more red blood cells.
At the recent SEC meeting for Oncology and Hematology held on the 27th of April 2023, the expert panel reviewed the proposal for manufacturing and marketing of Ferric Carboxymaltose Injection 50 mg/ml in fill volumes 100mg/2mL, 500mg/10mL, 750mg/15mL and 1000mg/20mL vials (Ferric Carboxymaltose Injection 50mg/mL in 2mL vial, 10mL vial, 15mL vial, and 20 mL vial) as an additional pack sizes indicated “for the treatment of iron deficiency in adults when oral iron preparations are ineffective or cannot be used”.
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