Submit More Data:  CDSCO Panel tells Boehringer Ingelheim on Veterinary Drug Afoxolaner

New Delhi: In response to the proposal presented by Boehringer Ingelheim, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended the firm submit the safety and efficacy data of the veterinary drug Afoxolaner 11.3mg/28.3 mg/68 mg/136 mg chewable tablets.

This came after the firm presented the proposal before the SEC committee.

Afoxolaner belongs to the isoxazoline class of insecticides and acaricides used as veterinary medicine to treat and prevent flea and tick infestations in dogs.Afoxolaner is used to treat and prevent flea and tick infestations in dogs. It is also used as a preventive for Lyme disease. After being ingested by a dog, afoxolaner is distributed throughout the dog's body. When fleas or ticks bite the dog, they are exposed to the drug and killed during their blood meal.

At the recent SEC meeting for Veterinary held on 24th February 2025, the expert panel reviewed the proposal presented by the proposal before the SEC committee.

After detailed deliberation, the committee recommended that the firm should submit the following and present the same in the next SEC meeting.

a) Details of safety and efficacy data, along with field trial data.

b) Justification for the selection of the number of animals in groups used in the study, along with the approved protocol for the field trial.

c) Justification data for products used in male dogs. However, the firm has not included the male dogs in the study.

d) Post-marketing surveillance data of the drugs.

e) Data on potential accumulation of drugs in the body due to long-term use must be submitted, including data on liver toxicity (hepatotoxicity) and kidney toxicity (renal toxicity).

f) What are the specific indications for use in pre-mating, mating, pregnant, and lactating dogs.

Also Read: CDSCO nod to AstraZeneca to import, sell hyperkalaemia treatment drug in India