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  • Submit Animal Toxicity...

Submit Animal Toxicity Data: CDSCO panel Tells Dr. Reddy's on Ferric carboxymaltose injection

Dr. Divya ColinWritten by Dr. Divya Colin Published On 2023-05-14T18:00:43+05:30  |  Updated On 14 May 2023 6:00 PM IST
Dr Reddys Labs inks pact with Henlius for commercialization of multiple myeloma injection HLX15 in US, Europe
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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.

This came after the firm presented 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”.

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”.

The committee also noted that the firm also presented the comparative pharmaceutical data with reference products along with justification for the bioequivalence (BE) study and clinical study waiver.
After detailed deliberation, the committee recommended that the firm should submit animal toxicity data as per New Drugs and Clinical Trial Rules 2019 for review by the committee for further consideration of the BE study and clinical study waiver.
Also Read:Zydus Healthcare Gets CDSCO Panel To Study Dydrogesterone Extended-release Tablets
dr reddyscdscoferric carboxymaltose injectioniron deficiency anaemia
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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