Leiner files for Chapter 11 bankruptcy protection
CARSON CITY, Calif. Leiner Health Products earlier this week filed voluntary petitions for relief under Chapter 11 of the U.S. Bankruptcy Code in Delaware. Leiner intends to use the Chapter 11 process to restructure its debt obligations and explore the sale of the business
In conjunction with the filing, a group of pre–petition lenders has agreed to provide Leiner with $74 million in debtor–in–possession financing that, together with the company’s existing cash flow, will enable Leiner to fulfill obligations associated with operating its business, including payments to suppliers and other business partners for goods delivered and services provided on or after today’s filing. This financing arrangement is subject to court approval.
CHPA president addresses OTC efficacy, drug abuse
WASHINGTON During her opening address to Consumer Healthcare Products Association members here, Linda Suydam, president of the CHPA, noted that two Food and Drug Administration meetings held last year have forever changed the over-the-counter regulatory landscape.
The two meetings Syudam referenced—an FDA advisory panel on the efficacy of children’s cough-cold medicine and a separate panel on the efficacy of phenylephrine—called into question the long-standing efficacy of monographed products. “What was learned from both of these meetings is that the regulatory landscape is changing,” she said. “We must move forward on the science supporting our product.”
To this end, CHPA is already committed to conducting pharmacokinetic and efficacy studies in pediatric populations for monographed OTC medicines.
Another point of concern identified by Suydam was the issue of dextromethorphan abuse. She commended the industry for pulling together on this issue, and through CHPA effectively raised awareness and education behind DXM abuse. “The level of cooperation among members this past year has been exceptional.”
Looking forward, the industry prognosis is positive, however not without its challenges. For example, “FDA’s chronic underfunding will take a long time to rectify,” Suydam said, regardless of whether a Democrat or a Republican wins the presidential election next year.
Study examines energy drinks’ tooth-damaging potential
CHICAGO A recently-published study has determined that energy drinks as corrosive to teeth as soft drinks.
The Academy of General Dentistry on Wednesday issued a press release regarding the results of a recent study that was published in the November/December 2007 issue of General Dentistry, the Academy of General Dentistry’s clinical, peer reviewed journal, which found that popular high-energy and sports drinks had the highest mean buffering capacity, resulting in the strongest potential for erosion of enamel.
According to the Academy, a beverage’s “buffering capacity,” or the ability to neutralize acid, plays a significant role in the cause of dental erosion.