HEALTH

AMO addresses contact lens safety for FDA’s opthalmic panel

BY Michael Johnsen

SANTA ANA, Calif. In an Advanced Medical Optics presentation before the Food and Drug Administration’s Ophthalmic Devices Panel of the Medical Devices Advisory Committee on Tuesday, the company addressed several general issues regarding the safety and effectiveness of contact lens solutions and demonstrated that infection control is a complex issue that involves more than the formulation of the solution itself.

“Rub and rinse has been proven to improve effectiveness against Acanthamoeba and other microorganisms,” stated David Hansen, director of professional services, AMO. “We firmly believe that it should be an integral part of an effective contact lens hygiene regimen.”

The company, which manufactures the Complete brand of eye care products, also shared information on ways to minimize the risk of infections such as Acanthamoeba keratitis among people who wear contact lenses and underscored the importance of proper handling, disinfection and hygiene when using contact lenses and contact lens products.

The company also addressed the FDA’s interest in evaluating preclinical microbiology test methods to better serve as predictors of real world product performance. AMO supports establishing standards for testing the effectiveness of contact lens solutions in effectively disinfecting against a broad range of organisms in the best interest of the patients who use its products. “We look forward to collaborating with the FDA on the most effective and appropriate path forward because we share their interest in controlling infections,” said Trenary. “Per our routine policy, we will comply with new FDA standards and/or labeling decisions and take any requested actions within the allotted timeframe.”

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Study suggests green tea effective on HPV-related warts

BY Alaric DeArment

NEW YORK A study published in the June issue of the Journal of Obstetrics and Gynecology has found that the green tea extract sinecatechins is useful for treating genital and anal warts.

The study found that 57 percent of patients who received ointment containing 10 or 15 percent sinecatechins were cleared of warts, compared to 34 percent of patients in the control group. Warts in at least three quarters of patients were cleared by at least 50 percent, compared to about half of patients in the control group.

The study examined 502 adults with between two and 30 warts over a 16-week period or until warts cleared.

Genital warts are caused by the human papillomavirus, also known as HPV and increase the risk of cervical cancer in women.

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NBTY proposes $230 million buyout of Leiner

BY Michael Johnsen

RONKONKOMA, N.Y. NBTY on May 30 proposed buying troubled private-label manufacturer Leiner Health Products in a deal worth $230 million plus the assumption of certain liabilities, according to an NBTY SEC filing.

The proposed buyout of Leiner, which filed for bankruptcy protection March 10, will be subject to higher or better offers and if any are proffered, the ownership of Leiner Health will be decided at a June 9 auction

If no higher or better offer is submitted by a competing bidder, the purchase transaction is expected to close no later than September.

Leiner in March filed its second bankruptcy in seven years, and is also emerging from a manufacturing scandal, in which the company last month pled guilty to mail fraud and forfeited $10 million to close the chapter on a U.S. Department of Justice investigation into Leiner’s now-closed Fort Mill, S.C. production facility following a Food and Drug Administration warning letter that “found many serious deviations [at that facility], some of which involved data manipulation and inadequate testing procedures.” The FDA concluded that “the products manufactured at [the Leiner] facility under these violative conditions put consumers at significant risk.”

Early last year, Leiner had stopped making over-the-counter drugs at that facility. In addition, Robert Kaminski resigned as company chief executive officer and was succeeded by Robert Reynolds.

The recent agreement in no way implicates or affects Leiner’s ability to manufacture and distribute vitamin and mineral products, the company stated.

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