Advertisement Mallinckrodt to submit OA drug sNDA - Pharmaceutical Business review
Pharmaceutical Business review is using cookies

ContinueLearn More
Close

Mallinckrodt to submit OA drug sNDA

Mallinckrodt, a US market partner of Nuvo Research, is set to submit the supplementary new drug application (sNDA) regulatory approval for Pennsaid Viscous Solution, a higher viscosity formulation of Pennsaid (diclofenac sodium topical solution) to treat osteoarthritis (OA) of the knee..

As per the agreement held during 2009, Pennsaid Viscous Solution is being handled by Nuvo’s licensee – Covidien and it has assumed all responsibility for managing, executing and paying for all development activities.

Covidien said that the data obtained through its recently completed clinical study can be used to support the sNDA.

Pennsaid Viscous Solution is under development for the treatment of the signs and symptoms of OA of the knee via twice-daily administration with a 2% diclofenac concentration.