For Immediate Release
April 16, 2015
At the request of the U.S. Food and Drug Administration and the U.S. Attorney for the Southern District of Florida, U.S. Marshals have seized unapproved prescription drug products valued at over $16 million from Stratus Pharmaceuticals, Inc., of Miami, Florida. Stratus Pharmaceuticals marketed and distributed unapproved prescription drug products that were manufactured by Sonar Products, Inc., of Carlstadt, New Jersey.
The seized products include:
- a solution used to treat excessive sweating;
- an antibiotic cleanser for treatment of skin conditions, such as acne, rosacea and seborrhea;
- a topical ointment used to treat wounds;
- a topical cream and gel to treat psoriasis, eczema and other skin conditions; and
- analgesic ear drops used to treat ear pain.
These products have not been proven safe and effective for their intended uses. The FDA recommends that consumers who believe they have drugs marketed by Stratus Pharmaceuticals consult a health care professional or pharmacist about discontinuing the use of these products and identifying an alternative treatment option.
“Companies that market unapproved drugs are placing consumers at risk because the products may not be safe, effective or made using quality manufacturing practices,” said Cynthia Schnedar, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to protecting consumers and will continue to take actions against companies that do not meet these standards.”
The U.S. Attorney’s Office filed a complaint on behalf of the FDA in the U.S. District Court for the Southern District of Florida, alleging that the products are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.
The complaint follows an FDA inspection conducted in November and December 2014 that revealed the company was marketing these drug products without FDA-approved drug applications. The new drug approval process plays an essential role in ensuring all drugs are safe and effective for their intended uses. Unapproved drugs have not been shown to be safe and effective, may be of uncertain quality and do not have FDA-approved labeling. As a result, these drugs may pose risks to patients.
The seizure of these products is consistent with the enforcement policy set forth in the FDA’s Marketed Unapproved Drugs Compliance Policy Guide, which, among its other provisions, provides notice that any product that is being marketed illegally and the persons responsible for causing the illegal marketing of the product are subject to FDA enforcement action at any time.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.