Lincoln pharma told to revise package insert before launching Sildenafil Citrate Oral Spray in Indian market

Now, in the 58th SEC (Reproductive & Urology) meeting dated 25.02.2021 at CDSCO, HQ New Delhi, Lincoln presented the package insert for the Sildenafil Citrate Oral Spray 12.5% w/v.

The committee reviewed the package insert in its recent meeting and responding to the presentation, committee recommended that the firm should revise the package insert with respect to:-

1. Specific adverse effects of Sildenafil Citrate Oral Spray 12.5% w/v on Oral mucosa.

2. The drugs to be sold on prescription by the specialist as notified for tablets.

3. Limit of dosage and number of sprays to be administered in 24 hrs.

4. Indication should be in-line with an already approved indication for Tablets.

The committee further recommended the firm to present the revised package insert before the committee prior to the launch of the product in the market..

"Further, firm is also required to present PSUR/PMS data before the committee in 6 months of launching the product in the Indian market," the SEC committe observed

Also Read:Sildenafil Citrate Tablets by Aurobindo Pharma receives a tentative USFDA nod