Lupin gets CDSCO Panel nod for Rifapentine Dispersible Tablet 150 mg
New Delhi: Granting the local clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved drug major Lupin's Rifapentine dispersible Tablets 150mg for already approved indication with the condition of conducting a Phase IV Clinical study.
This came after the firm presented their proposal for a grant of permission to manufacture and marketing of Rifapentine Dispersible Tablets 150mg (Additional Dosage Form) for an already approved indication along with the bioequivalence study report before the committee.
Rifapentine is an antitubercular agent and a leprostatic drug. Rifapentine is an antibacterial prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of active tuberculosis (TB) of the lungs. (Active TB is also called TB disease.) Rifapentine is also FDA-approved for the treatment of latent TB infection to prevent the infection from advancing to active TB disease.
It inhibits DNA-dependent RNA polymerase activity in susceptible cells. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme.
Rifapentine is used with other medications to treat active tuberculosis (TB; a serious infection that affects the lungs and sometimes other parts of the body) in adults and children 12 years of age and older.
At the recent SEC meeting for Antimicrobial and Antiviral held on 29th November 2023, the expert panel reviewed the proposal for grant of permission to manufacture and marketing of Rifapentine Dispersible Tablets 150mg (Additional Dosage Form) for an already approved indication along with the Bioequivalence study report presented by drug major Lupin.
After detailed deliberation, the committee recommended for approval of Rifapentine Dispersible Tablets 150mg for an already approved indication with a local clinical trial waiver with a condition to conduct a Phase IV Clinical study.
Accordingly, the expert panel suggested that the firm should submit a Phase IV protocol to CDSCO within 3 months of approval for further evaluation by the committee.
In addition, the committee stated that the firm should fulfill the requirements of CMC (chemistry, manufacturing, and controls) data before approval of the product.
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