CDSCO Panel Approves Updated Package Insert for Johnson and Johnson's Stelara
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended approval for the updated package insert of Ustekinumab Solution for Injection (Stelara 90 mg and 45 mg), and Ustekinumab Concentrate Solution for Intravenous Infusion, (Stelara 130 mg), manufactured by Johnson and Johnson (JnJ) Private Limited.
The revision covers all three formulations—Stelara Solution for Injection 90 mg and 45 mg, and Stelara Concentrate Solution for Intravenous Infusion 130 mg—and includes updates across multiple critical sections such as Use in Special Population, Drug Interactions, Adverse Reactions, Pharmacological Properties, and Pharmaceutical Particulars.
New Delhi: This came after the firm presented the proposal for an update in Package Insert for the changes in the sections of Use in special population, Drug interactions, Adverse reactions, pharmacological properties and Pharmaceutical particulars of the drug product Ustekinumab Solution for Injection-Stelara 90 mg and 45 mg—and Ustekinumab Concentrate Solution for Intravenous Infusion -Stelara 130mg based on the updates in the CCDS Version 50, 51 and 52.
Ustekinumab is a targeted antibody therapy used to manage inflammatory conditions such as plaque psoriasis, psoriatic arthritis, Crohn's Disease, and ulcerative colitis.
Ustekinumab is a human immunoglobulin (Ig) G1 kappa monoclonal antibody directed against interleukin(IL)-12 and IL-23, which are cytokines that are involved in immune and inflammatory responses. It was generated via recombinant human IL-12 immunization of human Ig (hu-Ig) transgenic mice. It is a targeted biologic disease-modifying anti-rheumatic drug (bDMARDs) that is used in the management of various inflammatory conditions that involve the activation of IL-12 and IL-23 signalling pathways.
After detailed deliberation, the committee recommended for approval of updated package insert for the proposed changes.
Also Read: JnJ seeks USFDA nod of Stelara for pediatric Crohn's disease
