Content about Fluocinolone acetonide

August 12, 2013

Perrigo Co. announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug applications for fluocinolone acetonide scalp oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Scalp Oil, and fluocinolone acetonide topical oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Body Oil.

ALLEGAN, Mich. — Perrigo Co. today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for fluocinolone acetonide scalp oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Scalp Oil, and fluocinolone acetonide topical oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Body Oil. Perrigo expects to begin shipments of both products next month.

February 12, 2013

A topical medication made by Galderma Labs for treating melasma of the face is now available in pharmacies, Galderma said.

FORT WORTH, Texas — A topical medication made by Galderma Labs for treating melasma of the face is now available in pharmacies, Galderma said.

Tri-Luma (fluocinolone acetonide 0.01%, hydroquinone 4%), tretinoin 0.05%) is described as the only Food and Drug Administration-approved triple combination topical product for the short-term treatment of moderate to severe melasma. The chronic skin condition affects more than 7 million people in the United States.

January 3, 2011

The Food and Drug Administration declined to approve a treatment for diabetic eye disease made by Alimera Sciences, the drug maker said Dec. 23.

ATLANTA — The Food and Drug Administration declined to approve a treatment for diabetic eye disease made by Alimera Sciences, the drug maker said Dec. 23.

In its complete response letter, the FDA requested additional safety and efficacy data for the drug, Iluvien (fluocinolone acetonide intravitreal insert), a treatment for diabetic macular edema, a problem that commonly affects people with diabetes.

August 31, 2010

The Food and Drug Administration has granted priority review for a diabetic macular edema treatment....

ATLANTA The Food and Drug Administration has granted priority review for a diabetic macular edema treatment.