Perrigo files FDA application for OTC generic of Monistat
ALLEGAN, Mich. Perrigo on Monday announced that it has filed an abbreviated new drug application for over-the-counter miconazole nitrate vaginal cream, 2 percent and Suppository, 1.2g, a generic version of Monistat 1 Combination Pack.
Monistat 1 Combination Pack is an antifungal medication indicated for the treatment of vaginal yeast infections, and had sales of approximately $50 million through food, drug and mass merchandisers for the 12 months ended March 2008, as measured by Information Resources, Inc., Perrigo reported.
According to Perrigo, McNeil challenged Perrigo’s ANDA with a suit filed Friday alleging patent infringement in the United States District Court for the District of New Jersey to prevent Perrigo from proceeding with the commercialization of its product.
Supplements gain ground in medical community
MINNEAPOLIS Nutritional supplements are gaining ground in the traditional medical community, according to an April report in the Chronicle, published by the investment banking firm of The Mercanti Group.
According to the report, consumers are increasingly moving toward alternative solutions to general wellness issues, spurred by high healthcare costs, quality of care issues and distrust of pharmaceuticals, among other reasons. In addition, supplements are gaining scientific credibility, thanks to Food and Drug Administration insistence on product quality and testing procedures, and increasing research by such federal agencies as the National Institute of Health.
“As consumers have become more interested in health and overall wellness, the market for products and services that provide a holistic approach has greatly increased,” stated author Eric Groman, a principal in Mercanti’s Los Angeles office. “Given that healthcare professionals tend to be more sensitive to product efficacy and the purity of ingredients, practitioner lines are generally characterized by high quality, and have more of a scientific foundation.”
Groman also noted that growth of nutritional supplements is much sharper in the practitioner setting compared with retail. “In this way, practitioner products generally address the quality concerns that have become increasingly important as consumers look to supplements as a way to remedy or alleviate real health problems.”
The report characterizes the $1.7 billion practitioner market as fairly fragmented and crowded. It identifies two of the leading players in the business as Metagenics, a 25-year-old company that has been a pioneer in the field of nutrigenomics, with products aimed at affecting genetic expression and that help prevent or manage chronic diseases; and Standard Process, an 80-year old company offering a full line of whole food and herbal supplements, as well as veterinary items.
Others active in the field that the report discusses are Allergy Research Group, Atrium Innovations, Designs for Health, Integrative Therapeutics, Seroyal International and Thome Research.
“The market is certainly ripe for future growth,” Groman said. “As quality and efficacy continue to be high on the list of consumer demand, and as supplements continue to gain credibility in traditional medical circles, practitioners will have a deepening impact and influence of broader activity in the market for alternative healthcare products.”
Survey prompts Westchester N.Y. to ponder dextromethorphan restrictions
WESTCHESTER , N.Y. A report published Monday stated that between 5 percent and 9 percent of 3,241 middle-schoolers have admitted consuming the cough ingredient dextromethorphan to get high, citing a Student Assistant Services study.
Westchester County is currently considering placing age restrictions on the sale of dextromethorphan, following the lead of Suffolk and Nassau counties—the two counties that make up Long Island.
The paper reported that as many as 10 adolescents have been treated at local hospitals for abusing cough medicine so far this year, according to the Long Island and Westchester Regional Poison and Drug Information Center.