Dr Reddy's Labs gets CDSCO panel nod to manufacture, market Ferric Carboxymaltose Inj to treat iron deficiency
New Delhi: In a significant development, Dr. Reddy's Laboratories has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market Ferric Carboxymaltose Injection of 50 mg/ml in fill volumes 100mg/2ml, 500mg/10ml, 750 mg/15ml and 1000mg/20ml vials indicated “for the treatment of iron deficiency in adults when oral iron preparations are ineffective or cannot be used”.
This came after the drug major Dr. Reddy's Laboratories submitted animal sub-acute toxicity data in light of the earlier, SEC recommendations dated 27.04.2023.
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.
Earlier, the Medical Dialogues Team had reported that at an earlier meeting, in response to the drug major Dr. Reddy's Laboratories' proposal to manufacture and market the Ferric Carboxymaltose Injection, the Central Drug Standard Control Organization (CDSCO) had opined that the firm should submit animal toxicity data as per New Drugs and Clinical Trial Rules 2019.
Now, in continuation, in light of the earlier, SEC recommendations dated 27.04.2023, Dr. Reddy's Laboratories submitted animal sub-acute toxicity data.
At the recent SEC meeting for Oncology and Haematology dated 08.06.2023, the expert panel examined the animal sub-acute toxicity data of Ferric carboxymaltose Injection 50mg/ml presented by drug major Dr. Reddy's Laboratories.
After detailed deliberation, the committee recommended the grant of permission for the manufacture and market of Ferric Carboxymaltose Injection 50 mg/ml in fill volumes of 100mg/2ml, 500mg/10ml, 750 mg/15ml and 1000mg/20ml vials (Ferric Carboxymaltose Injection 50 mg/ml in 2 ml vial, 10ml vial, 15ml vial, and 20 ml vial) for additional pack sizes.
