Content about Paracetamol

May 16, 2011

The Food and Drug Administration is convening its Nonprescription Drugs Advisory Committee Tuesday and Wednesday to debate mandating weight-based dosing for pediatric medicines containing acetaminophen on the Drug Facts label, as well as the potential expansion of dosing instructions to incorporate children under the age of 2 years old, according to material posted online by the FDA on Friday.

WASHINGTON — The Food and Drug Administration is convening its Nonprescription Drugs Advisory Committee Tuesday and Wednesday to debate mandating weight-based dosing for pediatric medicines containing acetaminophen on the Drug Facts label, as well as the potential expansion of dosing instructions to incorporate children under the age of 2 years old, according to material posted online by the FDA on Friday.

May 5, 2011

The Consumer Healthcare Products Association on Wednesday announced plans to convert liquid pediatric acetaminophen products to just one concentration.

WASHINGTON — The Consumer Healthcare Products Association on Wednesday announced plans to convert liquid pediatric acetaminophen products to just one concentration.

This voluntary change means the current children’s strength of liquid acetaminophen (160 mg/5 mL) will become the only liquid concentration available for all children younger than 12 years, and the current concentrated infant drops no longer will be sold.

April 28, 2011

The American Pain Foundation on Wednesday launched new information and resources on pain medication safety for acetaminophen and nonsteroidal anti-inflammatory drugs as part of its PainSafe educational initiative.

BALTIMORE — The American Pain Foundation on Wednesday launched new information and resources on pain medication safety for acetaminophen and nonsteroidal anti-inflammatory drugs as part of its PainSafe educational initiative.

The new information will be launched with a national public service announcement emphasizing the safe use of pain treatment options, particularly medications containing NSAIDs (aspirin, ibuprofen and naproxen) and acetaminophen (Tylenol and APAP).

March 7, 2011

Actavis last week named Lisa Buono to lead its over-the-counter drug division as part of the company’s strategic expansion of the division.

MORRISTOWN, N.J. — Actavis last week named Lisa Buono to lead its over-the-counter drug division as part of the company’s strategic expansion of the division.

As director of OTC, Buono will oversee the division’s day-to-day operations and will focus on identifying and capitalizing on new product opportunities. Actavis manufactures and distributes numerous nonprescription liquids, creams and ointments sold under the Actavis label and its customers’ own brands, as well as FeverAll brand acetaminophen suppositories.

February 18, 2011

MOUNT KISCO, N.Y. — Prestige Brands became one of the first cough-cold marketers to develop a branded smart-phone app to help moms hone in on the most appropriate 
PediaCare remedy for their sick children. It’s not a bad play; a recent Millennial Media report indicated that in 2010, 32% of moms owned a smart phone, versus 20% in 2009.


January 14, 2011

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

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.

January 13, 2011

The Food and Drug Administration is capping the amount of the painkiller acetaminophen in prescription drugs due to the risk of liver toxicity, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration is capping the amount of the painkiller acetaminophen in prescription drugs due to the risk of liver toxicity, the agency said Thursday.

November 21, 2010

A drug maker will pull a common prescription painkiller from the market following the release...

SILVER SPRING, Md. A drug maker will pull a common prescription painkiller from the market following the release of clinical data that it could cause heart problems.

 

November 14, 2010

On Tuesday, Lifetime Television’s program “The Balancing Act” will feature an appearance from Sarita Thapar,...

MORRISTOWN, N.J. — On Tuesday, Lifetime Television’s program “The Balancing Act” will feature an appearance from Sarita Thapar, director of medical affairs for Actavis, to discuss the benefits of the company’s pediatric suppository FeverAll, Actavis announced last week.

August 9, 2010

Prestige Brands has expanded its Little Remedies product line with a new analgesic for infants,...

IRVINGTON, N.Y. Prestige Brands has expanded its Little Remedies product line with a new analgesic for infants, toddlers and children.

New Little Fevers is concentrated infant drops with acetaminophen and indicated for the treatment of temporary fever and minor aches and pains which may be associated with the common cold, flu, headache, sore throat or toothache. The product is specially formulated to provide small concentrated doses for easier administration, Presitge Brands said.

 

August 2, 2010

Actavis on Tuesday announced the reintroduction of its FeverAll acetaminophen suppositories to retail following the...

MORRISTOWN, N.J. Actavis on Tuesday announced the reintroduction of its FeverAll acetaminophen suppositories to retail following the completion of updates to the company’s manufacturing facility.

The brand will be marketed in publications read by new parents and healthcare professionals, the company stated.

 

June 3, 2010

One-in-5 high school students have abused prescription drugs, according to a survey released Thursday by...

February 17, 2010

Ibuprofen may soon join aspirin as a daily analgesic prophylactic....

August 18, 2009

Johnson & Johnson’s Bengay PM product ought to spice up arthritis relievers on two accounts...

August 9, 2009

Three Food and Drug Administration advisory committees voted on sweeping changes regarding the marketing, merchandising and formulation of acetaminophen products last month, though the proposed changes fell short of pulling combination products containing acetaminophen off the market. This ECRM section covers intricacies of the FDA committees' decision, as well as external analgesics, foot care, PSE regulations and baby care.

Three Food and Drug Administration advisory committees voted on sweeping changes regarding the marketing, merchandising and formulation of acetaminophen products last month, though the proposed changes fell short of pulling combination products containing acetaminophen off the market. This ECRM section covers intricacies of the FDA committees' decision, as well as external analgesics, foot care, PSE regulations and baby care. Click below to download the PDF of "ECRM Health Care."

July 12, 2009

Sales of liquid Tylenol formulations, both adult and children, totaled $104.5 million across food, drug...

NEW YORK Sales of liquid Tylenol formulations, both adult and children, totaled $104.5 million across food, drug and mass (minus Walmart) for the 52 weeks ended May 17, according to Information Resources Inc. Internal analgesics tablet sales of Tylenol SKUs (across the top 20 brands) generated another $480.9 million. That’s more than $500 million in annual revenue, not including Walmart, potentially impacted by a future Food and Drug Administration decision. That’s not even representative of all acetaminophen sales.

 

July 5, 2009

While the impetus for this multiple advisory committee meeting and the Food and Drug Administration’s...

NEW YORK While the impetus for this multiple advisory committee meeting and the Food and Drug Administration’s working group that first examined this issue had been in the works long before the Obama administration took office — and consequently the new FDA took hold — there has been some concern that an overly zealous agency is placing any shred of safety concern ahead of consumer access — no matter how miniscule that safety risk may be.

 

October 17, 2007

Four physicians, including Michael Shannon, professor of pediatrics at Harvard Medical School, and Daniel Levy,...