FougeraÂ® Announces First Generic Approval of Adapalene Cream 0.1% (Rx), Equivalent to DifferinÂ®
MELVILLE, N.Y., July 6 /PRNewswire/ — E. Fougera & Co., a leading specialty pharmaceutical manufacturer, announced it has received first generic approval from the FDA for Adapalene Cream 0.1% (Rx). Fougera’s Adapalene Cream 0.1% is rated AB, generically equivalent to DifferinÃ‚® by Galderma Pharmaceuticals. According to industry data, U.S. sales of the brand named product in 2009 exceeded $55 million. This approval also marks the fourth product approval that the FDA has granted to Fougera this year.
“Fougera’s commitment to develop this first-to-market product as a cost-effective generic provides healthcare professionals the ability to prescribe a more affordable treatment, thereby making it accessible to more patients,” said David Klaum, Sr. Vice President and General Manager of Fougera.
Adapalene Cream 0.1% is indicated for the treatment of acne vulgaris. Full Prescribing Information for Adapalene Cream 0.1% is available at www.fougera.com or can be requested by calling (800) 645-9833.
Important Safety Information
Adapalene cream 0.1% is indicated for the topical treatment of acne vulgaris in patients 12 years and older. The most common side effects reported with use of adapalene 0.1% products include itching, dryness, redness, stinging, burning, and scaling or peeling. Most adverse events reported were mild to moderate in severity, occurred early in treatment and decreased thereafter. Excessive exposure to sunlight and sunlamps should be avoided during treatment and use of sunscreen products and protective clothing is recommended. As with other acne medications, overexposure to extreme wind or cold or use of irritating skin care products may aggravate the skin. Patients should talk to the doctor if these effects become bothersome.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Founded in 1849, Fougera is a division of Nycomed US Inc. and is the leading manufacturer and distributor of a wide range of topical products. For more information on Fougera’s complete line of products, please call Fougera Customer Service at (800) 645-9833 or visit the company online at www.fougera.com.
About Nycomed US Inc.
Nycomed US Inc. is a subsidiary of Nycomed. In addition to Fougera, Nycomed US Inc. operates two additional divisions of specialty pharmaceuticals. The PharmaDerm division is dedicated to developing and commercializing novel prescription products to treat diseases and conditions of the skin–the largest organ of the human body. Nycomed US Inc. also markets and sells Savage Laboratories products, which focus on emergency care. More information is available at www.nycomedus.com.