FDA Seeks Permanent Injunction Against California Pharmaceutical Company

Targeted News Service |


WASHINGTON, July 1 -- The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release: On June 25, the U.S. Department of Justice, at the request of the U.S. Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede, Inc. (Laclede) of Rancho Dominguez, California, and its president, Michael A. Pellico. The complaint claims that Laclede illegally distributes over-the-counter vaginal drug products without required FDA approval. According to the complaint, Laclede is in violation of the Federal Food, Drug, and Cosmetic Act for introducing unapproved and improperly labeled (misbranded) drugs for sale across the country. The prebiotic vaginal products named in the complaint are: Luvena Prebiotic Vaginal Moisturizer and Lubricant Luvena Prebiotic Enhanced Personal Lubricant Luvena Prebiotic Feminine Wipes Luvena Prebiotic Daily Therapeutic Wash The complaint requests, among other things, that the court issue a permanent injunction order requiring Laclede to cease distribution of these drug products until the company obtains an approved new drug application from the FDA or until all drug claims have been removed from the products' labels, marketing materials, and any websites controlled by or related to Laclede. "The drug approval process is critical to ensuring that drugs are safe and effective for their intended uses," said Carol Bennett, acting director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. "The FDA will take swift action when companies bypass this important process established to protect consumers from harmful products." Since 2010, the FDA has repeatedly told the company that it must obtain the FDA's approval before selling its drug products. According to the complaint, the company subsequently marketed and distributed the unapproved drug products, despite the FDA's warnings. TNS 30VianaGem - 140702-4786166 30VianaGem

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer

Companies

Symbol Name Price Change % Volume
SORRF Sonae Sierra Brasil Ord n/a n/a n/a 0

Comments

Emerging Growth

Immunovaccine Inc.

Immunovaccine Inc is clinical stage biopharmaceutical company. The Company develops products based on its proprietary vaccine enhancement platform in T cell activating therapies for cancer.

Private Markets

Voleo

Voleo is a free download that allows you to form investment clubs with your friends, family, colleagues, classmates, teammates…basically anyone you know and trust. Invest and manage a stock portfolio…

iPRO Network, LLC

We provide the platform, tools, and resources to empower individuals and professionals to market desirable goods and services to the public, taking the place of traditional methods of commerce.