Hyland’s teething tablets recalled
LOS ANGELES Standard Homeopathic Co., which manufactures homeopathic products under the Hyland’s brand in mass retail, on Saturday recalled its Hyland’s teething tablets “in an abundance of caution due to an FDA investigation of its manufacturing facility,” the company stated.
Adverse events have been reported, but the Food and Drug Administration has said that a conclusive link has not been determined. The company, in working with the FDA, has identified manufacturing processes of teething tablets that can be improved to ensure uniformity in dosage. As a homeopathic product, Hyland’s teething tablets have a wide margin of safety that protects consumers from harm.
“We initiated this voluntary recall to ensure our consumers know that their families’ safety and health are our top priorities,” stated Mark Phillips, president and chief pharmacist of Standard Homeopathic Co. “We are committed to maintaining and deserving the trust they have placed in Hyland’s. We have worked for 107 years to build relationships with our consumers. We intend to preserve that tradition of trust.”
After in-depth analysis, a comprehensive review of the company’s adverse event report log and more than 85 years of safe usage, the company is confident that Hyland’s teething tablets are safe for infants and toddlers. Hyland’s teething tablets are manufactured in the United States and are distributed throughout North America.
In addition to the product recall, Standard Homeopathic Co. is refining its production, packaging and testing protocols. Throughout the process, Standard Homeopathic Co. will continue to closely monitor and evaluate the situation and consult with the FDA.
Arena, Eisai receive complete response letter for lorcaserin
SAN DIEGO The Food and Drug Administration declined to approve a regulatory approval application from Arena Pharmaceuticals and Eisai for a drug to treat obesity, the two companies said Saturday.
The FDA issued a complete response letter for the drug lorcaserin, designed for weight management and weight loss in patients who are overweight or obese and have at least one co-morbid condition. The FDA issues a complete response letter when it finishes reviewing an approval application, but issues remain that preclude final approval.
The FDA told the companies that it found problems regarding tumors in the mammary glands of rats receiving the drug and issues surrounding the efficacy of the drug in some patients.
“This is an important step for us toward the FDA’s approval of lorcaserin,” Arena president and CEO Jack Lief said. “While the complete response letter provides us with recommendations from the agency, we intend to meet with the FDA to obtain further clarity on the approval path and timeline.”
CHPA names Melville its new president
WASHINGTON —Scott Melville has been named the new president of the Consumer Healthcare Products Association, succeeding Linda Suydam, who is retiring after eight years with CHPA. The news becomes official Nov. 1.
Prior to the announcement, Melville served as SVP government affairs and general counsel for the Healthcare Distribution Management Association. Before joining HDMA, Melville was as an attorney and head of government relations for Cephalon. A veteran facilitator, familiar with health care and the vital role over-the-counter medicines and natural products play in today’s healthcare system, Melville also is a former staffer for Rep. Jerry Lewis, R-Calif.
At CHPA, Melville will have an opportunity to bring all of his decades of experience as a healthcare sector advocate to bear. With healthcare reform on the line and millions of baby boomers hitting their 60s, CHPA chairman Christopher DeWolf said that Melville’s “experience in public policy, coalition building and working with government officials and key stakeholders will be invaluable in guiding the industry through the rapidly changing healthcare environment.”