Lincoln pharma told to revise package insert before launching Sildenafil Citrate Oral Spray in Indian market
New Delhi: Pharma Company, Lincoln Pharmaceuticals has been directed by the Central Drugs Standard Control Organization (CDSCO) Committee to revise the package insert of Sildenafil Citrate Oral Spray 12.5% w/v before launching the said drug in the market.
Sildenafil Citrate is already sold in tablet form by Lincoln Pharmaceutical under market name SANTRO 50 mg TAB and SANTRO 100 mg TAB. It is used to treat erectile dysfunction in adult men.
Moving to launch the said drug in a spray dosage form, the bioequivalence study report of Sildenafil Citrate Oral Spray 12.5% w/v had been submitted by the firm last year at 51st Subject Expert Committee (SEC) meeting held on 13.07.2020 at CDSCO HQ New Delhi. Responding to this the committee recommended that the firm should submit raw data of Bioequivalence study report and package insert of the product including recommended dose and dosage of administration etc. for further review by the committee.
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