Content about Analgesics



McNeil Consumer Healthcare recently parlayed its Tylenol brand franchise into external analgesics to quite a bit of success. For the four weeks ended Dec. 26, 2010, Precise “from the makers of Tylenol” became the No. 3 best-selling heat patch, with $1.9 million in sales across food, drug and mass (excluding Walmart), according to Symphony­IRI Group. And its pain-relieving cream similarly broke in among the top-selling brands — No. 9 with $1.3 million in sales for the four-week period.

ST. LOUIS — The Food and Drug Administration has approved a painkiller delivered through a skin patch made by Mallinckrodt, the generic drug maker said Friday.

Mallinckrodt, part of Covidien, said the FDA approved its fentanyl transdermal system patch.

The patch is a generic version of Johnson & Johnson’s Duragesic. The drug, an opioid and Class II controlled substance, is used for managing persistent, moderate-to-severe pain that requires continuous opioid administration.

NEW BRUNSWICK, N.J. — Johnson & Johnson on Tuesday postponed its plans to begin folding many of its recalled products, including several pediatric formulations, back onto retail shelves until later this fall.

However, when those products are ready to occupy the brand blocks McNeil has carved out for Tylenol and others, J&J will be placing a significant emphasis on reacquainting those products with quality in the consumer’s mind.

NASHVILLE, Tenn. — The Food and Drug Administration has approved a new formulation of a drug for treating acetaminophen poisoning.

Cumberland Pharmaceuticals announced Thursday that the agency had approved a version of Acetadote (acetylcysteine) injection that does not contain preservatives or stabilization and chelating agents, and will replace the currently marketed version. The drug originally was approved in 2004.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating pain in cancer patients, the agency said Friday.

The FDA announced the approval of ProStrakan’s Abstral (fentanyl) transmucosal tablets for the management of pain that appears suddenly for short periods and is not alleviated by a patient’s normal pain-management plan, also known as breakthrough pain. The tablets are designed for administration on the soft surfaces of the mouth, including inside the cheek, gums and tongue, as well as the nasal passages or the throat.

BRISTOL, Tenn. — Drug makers King Pharmaceuticals and Acura Pharmaceuticals have submitted a regulatory approval application to the Food and Drug Administration for an opioid pain reliever.

The two drug makers announced Tuesday the submission for Acurox (oxycodone hydrochloride), an immediate-release tablet for relief of moderate to severe pain.

The tablets use Acura’s aversion technology, designed to deter abuse of the drug by dissolving or crushing the pills.

BOSTON — Johnson & Johnson recalled lots of its Tylenol Cold Multi-Symptom liquid products due to insufficient labeling, the company said Wednesday.

The products are not being recalled due to reports of any adverse events associated with taking the product, the company added.

Earlier this week, the company recalled additional lots of millions of packages of Children's Benadryl and children's Motrin.

MORRISTOWN, N.J. Actavis last week recalled 18 lots of its patches designed to treat persistent, moderate to severe chronic pain.

FORT WASHINGTON, Pa. McNeil Consumer Healthcare has pulled a lot of Tylenol off the market, following complaints of a musty odor.

McNeil said the uncharacteristic odor is thought to be caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole. The lot of Tylenol 8-Hour, 50-count bottles are part of lot number BCM155 and carry the following UPC code: 3 0045-0297-51 8.

SILVER SPRING, Md. The Food and Drug Administration approved a drug to treat and prevent relapse after patients with opioid dependence have undergone detoxification treatment.

Vivitrol is an extended-release formulation of naltrexone -- which works to block opioid receptors in the brain -- administered by intramuscular injection once a month. It only is administered by a physician.