B. Braun’s wound management gel available for OTC use
BETHLEHEM, Pa. — B. Braun has launched its Prontosan wound management gel — a product used in the healthcare setting for cleaning wounds, as well as moistening and lubricating absorbent wound dressings — for over-the-counter use.
The ready-to-use gel contains PHMB and betaine, the surfactant for the cleansing and moistening of wounds. Its nontoxic and biocompatible formula also offers excellent skin tolerance, the company said.
"Effective wound care management no longer needs to be limited to within healthcare facility walls," said Mike Kelly, director of marketing, infection control products for B. Braun. "The 510(k) clearance [which occurred in November 2010] for OTC use of Prontosan wound management gel advances B. Braun’s commitment to infection prevention, helping to provide solutions that positively impact patients’ care in a physician’s office, acute care setting or in a patient’s home."
Pernix, ParaPro to promote prescription pediculicide if approved
MAGNOLIA, Texas — Pernix Therapeutics Holdings on Wednesday announced an exclusive co-promotion agreement with ParaPro for a medication to treat head lice.
A new drug application for the prescription product currently is under review by the Food and Drug Administration. The proposed medication contains the active ingredient spinosad, which is derived from a naturally occurring soil bacterium.
Under the terms of the agreement, if the drug containing spinosad is approved by the FDA, Pernix and ParaPro exclusively will co-promote the medication with a combined sales force in the United States. Pernix would leverage its established pediatric sales force to promote the drug to healthcare professionals who treat human head lice.
If approved, the product is expected to be available in the first half of 2011.
McNeil issues recall at wholesaler level
FORT WASHINGTON, Pa. — In consultation with the Food and Drug Administration, McNeil Consumer Healthcare on Friday voluntarily recalled certain lots of Tylenol 8 Hour, Tylenol Arthritis Pain and Tylenol upper respiratory products, as well as certain lots of Benadryl, Sudafed PE and Sinutab products at the wholesale level.
All of the products were manufactured at the McNeil plant in Fort Washington, Pa., prior to April 2010, when production at the facility was suspended. McNeil stated the company has initiated the recall as a precautionary measure after an extensive review of past production records found instances where equipment-cleaning procedures were insufficient or that cleaning was not adequately documented. However, it is very unlikely that this impacted the quality of these products, McNeil stated.
McNeil also initiated a voluntary recall of certain product lots of Rolaids Multi-Symptom Berry tablets distributed in the United States, in order to update the labeling. The company initiated the recall after determining that the product labeling does not include the language "Does not meet USP" as required by regulation.
Because the recalls are being initiated at the wholesale level, no action is required by consumers or healthcare providers, and consumers can continue to use the product, McNeil stated. These actions are not being undertaken on the basis of adverse events, the company added.