Lupin receives FDA OK for generic Derma Smoothe/FS

Lupin’s subsidiary, Novel Laboratories has gained permission from the Food and Drug Administration for Fluocinolone Acetonide Oil, 0.01% (Body Oil), which is a generic of Hill Dermaceuticals’ Derma-Smoothe/FS.

Fluocinolone acetonide oil is used in adult patients for psoriasis of the scalp.

This product will be manufactured at Lupin’s Somerset, N.J. facility.

[Read more: Lupin receives FDA OK for generic Banzel

Fluocinolone Acetonide Oil (RLD Derma-Smoothe/FS) had a market value of roughly $10 million, per  IQVIA MAT June 2023 data.

[Read more: Lupin receives tentative nod from FDA for DETAF]