clindamycin phosphate and benzoyl peroxide

FDA Drug Profile — Clindamycin Phosphate and Benzoyl Peroxide, Neuac

Drug Details

Generic Name
clindamycin phosphate and benzoyl peroxide
Brand Names
Clindamycin Phosphate and Benzoyl Peroxide, Neuac
Application Number
ANDA065443
Sponsor
Mylan Pharmaceuticals Inc.
NDC Codes
3
Dosage Forms
KIT, GEL
Routes
TOPICAL
Active Ingredients
BENZOYL PEROXIDE, CLINDAMYCIN PHOSPHATE

Indications and Usage

1 INDICATIONS AND USAGE Neuac ® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of inflammatory acne vulgaris. ( 1.1 ) Limitation of Use: Neuac ® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. ( 1.2 ) 1.1 Indication Neuac ® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older. 1.2 Limitations of Use Neuac ® (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne.