Content about Analgesics

September 26, 2011

With Tylenol coming back to cough-cold and analgesic aisles over the next six months, you can bet the brand will soon resume its status as the cleanup hitter for Team OTC. That not only means a reshuffling of the lineup, but the respective No. 9 hitters will be packing their bags for a trip back to the minors.

WHAT IT MEANS AND WHY IT'S IMPORTANT — With Tylenol coming back to cough-cold and analgesic aisles over the next six months, you can bet the brand will soon resume its status as the cleanup hitter for Team OTC. That not only means a reshuffling of the lineup, but the respective No. 9 hitters will be packing their bags for a trip back to the minors.

(THE NEWS: Report: J&J resumes shipping of Tylenol product. For the full story, click here)

September 22, 2011

It seems that Tylenol Cold & Flu Severe caplets are making their way back to store shelves, according to published reports.

NEW YORK — It seems that Tylenol Cold & Flu Severe caplets are making their way back to store shelves, according to published reports.

According to several reports, McNeil Consumer Healthcare spokeswoman Bonnie Jacobs confirmed that the product, which is designated for adult use, will begin shipping this week.

McNeil Consumer Healthcare, a Johnson & Johnson subsidiary, recalled several lots of Tylenol products due to reports of uncharacteristic odor, which was linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA).

September 12, 2011

Perrigo this summer developed a healthcare professional outreach strategy, educating pediatricians, for example, around the company’s new infants’ and children’s acetaminophen dosing and packaging changes.

ALLEGAN, Mich. — Perrigo this summer developed a healthcare professional outreach strategy, educating pediatricians, for example, around the company’s new infants’ and children’s acetaminophen dosing and packaging changes. It’s the kind of outreach that’s more often associated with an OTC manufacturer supporting a branded product, not the store-brand medicines that Perrigo produces. 


September 9, 2011

The Food and Drug Administration has approved a generic drug made by Mylan for treating allergies.

PITTSBURGH — The Food and Drug Administration has approved a generic drug made by Mylan for treating allergies.

Mylan announced Friday the approval of promethazine hydrochloride tablets in the 12.5-mg, 25-mg and 50-mg strengths.

Promethazine hydrochloride tablets, which are manufactured by several companies, had sales of about $42 million during the 12-month period ended in June, according to IMS Health.

September 1, 2011

Proton-pump inhibitors may aggravate, not soothe, stomach discomfort created through chronic use of nonsteroidal anti-inflammatory drugs for such conditions as arthritis, according to research released Thursday.

HAMILTON, Ontario — Proton-pump inhibitors may aggravate, not soothe, stomach discomfort created through chronic use of nonsteroidal anti-inflammatory drugs for such conditions as arthritis, according to research released Thursday.

In a study published in the medical journal Gastroenterology, principal investigator John Wallace reported the extent of the hard-to-detect damage caused to the small intestine only recently has been discovered through use of small video cameras swallowed like pills.

August 31, 2011

Lupin has received final approval from the Food and Drug Administration for a generic version of a drug designed to treat moderate to moderately severe chronic pain in adults who require around-the-clock treatment for an extended period of time.

BALTIMORE — Lupin has received final approval from the Food and Drug Administration for its version of a drug designed to treat moderate to moderately severe chronic pain in adults who require around-the-clock treatment for an extended period of time.

Lupin said that it received final approval for its abbreviated new drug application for tramadol hydrochloride extended-release tablets in the 100-mg, 200-mg and 300-mg strengths. The drug is a generic version of Ultram ER tablets, which is marketed by Johnson & Johnson subsidiary Ortho-McNeil-Janssen Pharmaceuticals.

August 30, 2011

The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.

TARRYTOWN, N.Y. — The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.

The two drug makers announced Tuesday that the FDA had accepted their supplemental new drug application for Relistor (methylnaltrexone bromide), an injectable drug for treating opioid-induced constipation.

August 26, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating chronic pain, a J&J subsidiary said Friday.

RARITAN, N.J. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating chronic pain, a J&J subsidiary said Friday.

The FDA approved Janssen Pharmaceuticals' Nucynta ER (tapentadol) tablets, an extended-release drug for moderate to severe chronic pain in adults for whom a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

August 12, 2011

Lannett announced that it has started shipping morphine sulfate oral solution, a painkiller approved by the Food and Drug Administration in June.

PHILADELPHIA—Lannett has started shipping a painkiller product approved by the Food and Drug Administration in June, the company said.

Lannett announced the shipment of morphine sulfate oral solution. Lannett sought FDA approval using a 505(b)(2) new drug application. Sales of morphine sulfate oral solution at average wholesale price were $31.7 million during the 12-month period ending in June, according to Wolters Kluwer.

August 8, 2011

Uniform concentrations of single-ingredient liquid pediatric acetaminophen medicines have been making their way to the shelf as promised by the Consumer Healthcare Products Association earlier this year, as evidenced by these new product facings from PediaCare and Triaminic.

WASHINGTON — Uniform concentrations of single-ingredient liquid pediatric acetaminophen medicines have been making their way to the shelf as promised by the Consumer Healthcare Products Association earlier this year, as evidenced by these new product facings from PediaCare and Triaminic. Note, too, that both new formulations feature uniform age-appropriate dosing devices, in this case syringes.

August 2, 2011

The Food and Drug Administration has approved an opioid painkiller made by Covidien's generic drug division, the medical supply company said.

ST. LOUIS — The Food and Drug Administration has approved an opioid painkiller made by Covidien's generic drug division, the medical supply company said.

Covidien said the FDA approved Mallinckrodt's morphine sulfate oral solution, used to relieve moderate to severe acute and chronic pain in opioid-tolerant patients.

July 29, 2011

Prestige Brands on Thursday announced the launch of its new PediaCare and Little Remedies single-concentration acetaminophen products.

IRVINGTON, N.Y. — Prestige Brands on Thursday announced the launch of its new PediaCare and Little Remedies single-concentration acetaminophen products.

The new standard concentration liquid acetaminophen products for infants and children under 2 years of age will be 160 mg/5 mL.

“The voluntary changes to single-concentration acetaminophen dosing demonstrate the continued commitment to accuracy, safety and innovation from PediaCare and Little Remedies," Prestige VP over-the-counter products Albert Hwang said.

July 28, 2011

McNeil Consumer Healthcare on Thursday announced plans for new dosing instructions, lowering the maximum daily dose for single-ingredient Extra Strength Tylenol (acetaminophen) products sold in the United States from eight pills per day (4,000 mg) to six pills per day (3,000 mg).

FORT WASHINGTON, Pa. — McNeil Consumer Healthcare on Thursday announced plans for new dosing instructions, lowering the maximum daily dose for single-ingredient Extra Strength Tylenol (acetaminophen) products sold in the United States from eight pills per day (4,000 mg) to six pills per day (3,000 mg).

July 22, 2011

The Food and Drug Administration on Friday refreshed its Consumer Updates page with information regarding the danger of acetaminophen overdose in children.

ROCKVILLE, Md. — The Food and Drug Administration on Friday refreshed its Consumer Updates page with information regarding the danger of acetaminophen overdose in children.

“You’re in the drug store, looking for a fever-reducing medicine for your children,” the message begins. “They range in age from 6 months to 7 years, and you want to buy one product you can use for all of them. So you buy liquid acetaminophen in concentrated drops for infants, figuring you can use the dropper for the baby and a teaspoon for the oldest.”

July 21, 2011

The Food and Drug Administration has approved a risk evaluation and mitigation strategy for two painkillers made by Cephalon, the drug maker said Thursday.

FRAZER, Pa. — The Food and Drug Administration has approved a risk evaluation and mitigation strategy for two painkillers made by Cephalon, the drug maker said Thursday.

The FDA approved a REMS for Fentora (fentanyl) buccal tablets and Actiq (oral transmucosal fentanyl citrate). Both drugs are used for managing breakthrough pain in cancer patients who have become tolerant of opioid drugs.

July 20, 2011

Purdue Pharma has launched a new website designed to combat abuse of prescription drugs, the company said Wednesday.

STAMFORD, Conn. — Purdue Pharma has launched a new website designed to combat abuse of prescription drugs, the company said Wednesday.

The website, RxSafetyMatters.org, is designed to help healthcare professionals, police and community organizations combat prescription drug diversion and abuse. Purdue is the developer of OxyContin (oxycodone), an extended-release painkiller that is frequently a target of drug abusers.

July 18, 2011

Australian drug maker QRxPharma is seeking approval for a drug that combines two painkillers in one pill, the company said Monday.

SYDNEY — Australian drug maker QRxPharma is seeking approval for a drug that combines two painkillers in one pill, the company said Monday.

QRxPharma announced that it had filed a regulatory approval application with the Food and Drug Administration for MoxDuo IR (morphine and oxycodone). The drug is designed to release both drugs into the body immediately.

July 5, 2011

McNeil Consumer Healthcare’s foray into heat patches has proven a success. Tylenol Precise is the No. 2 brand across heat and ice packs, falling in behind Pfizer’s ThermaCare.

NEW YORK — McNeil Consumer Healthcare’s foray into heat patches has proven a success. Tylenol Precise is the No. 2 brand across heat and ice packs, falling in behind Pfizer’s ThermaCare. Within its first year on the shelf, Tylenol Precise has generated $6.1 million in sales for the 52 weeks ended April 17, according to SymphonyIRI Group data across food, drug and mass (excluding Walmart). 


The Tylenol Precise patches retail for around $7.99.

June 29, 2011

McNeil Consumer Healthcare on Tuesday initiated another recall at the retail level of one product lot (60,912 bottles) of Tylenol extra strength caplets in 225-count bottles because of a small number of odor reports, including a musty, moldy odor.

FORT WASHINGTON, Pa. — McNeil Consumer Healthcare on Tuesday initiated another recall at the retail level of one product lot (60,912 bottles) of Tylenol extra strength caplets in 225-count bottles because of a small number of odor reports, including a musty, moldy odor.

The uncharacteristic musty, moldy odor has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA).

The product lot number (ABA619) for the recalled product can be found on the side of the bottle label. The recalled product was manufactured in February 2009.

June 22, 2011

The Food and Drug Administration has approved a medication designed to treat acute and chronic moderate to severe pain, where the use of an opioid analgesic is suitable.

NEW YORK — The Food and Drug Administration has approved a medication designed to treat acute and chronic moderate to severe pain, where the use of an opioid analgesic is suitable.

Pfizer and Acura Pharmaceuticals said that their drug Oxecta (oxycodone HCl, USP tablets) is the first tamper-resistant medication designed to deter abuse and misuse with Aversion technology, which is being licensed by Pfizer from Acura.

June 17, 2011

The Food and Drug Administration has approved a drug for arthritis made by Watson Pharmaceuticals, Watson said Friday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a drug for arthritis made by Watson Pharmaceuticals, Watson said Friday.

The drug maker announced the approval of nabumetone tablets in the 500-mg and 750-mg strength. The drug is used to treat signs and symptoms of rheumatoid arthritis and osteoarthritis.

Nabumetone had sales of $58 million during the 12-month period ended in April, according to IMS Health.

June 14, 2011

The Food and Drug Administration has approved two cough-cold medications made by Cypress Pharmaceutical, the company said Monday.

MADISON, Miss. — The Food and Drug Administration has approved two cough-cold medications made by Cypress Pharmaceutical, the company said Monday.

Cypress announced the approval of Zutripro (hydrocodone bitartrate, chlorpheniramine maleate and pseudoephedrine hydrochloride) and Rezira (hydrocodone bitartrate and pseudoephedrine). Both drugs are oral solutions and, because they contain the opioid hydrocodone, are classified as schedule III controlled substances by the Drug Enforcement Administration. Cypress subsidiary Hawthorn Pharmaceuticals will market the drugs.

June 7, 2011

Generic drug maker Lannett said that the Food and Drug Administration has assigned a Prescription Drug User Fee Act action date for one of Lannett's drugs.

PHILADELPHIA — Generic drug maker Lannett said that the Food and Drug Administration has assigned a Prescription Drug User Fee Act action date for one of Lannett's drugs.

The FDA said it revised its PDUFA goal date of June 23 for Lannett's new drug application for morphine sulfate oral solution.

"With a revised PDUFA date in 17 days, we are preparing for the relaunch of our morphine sulfate oral solution product, if approved,” Lannett president and CEO Arthur Bedrosian said.

May 26, 2011

Medication nonadherence is sort of similar to substance abuse: It’s a societal issue that stems from multiple causes and as such, probably will never completely disappear; however, it still can be mitigated. And because it stems from multiple causes, effectively combating it also requires multiple strategies.

WHAT IT MEANS AND WHY IT'S IMPORTANT — Medication nonadherence is sort of similar to substance abuse: It’s a societal issue that stems from multiple causes and as such, probably will never completely disappear; however, it still can be mitigated. And because it stems from multiple causes, effectively combating it also requires multiple strategies.

May 25, 2011

Mylan has launched a generic version of an opioid painkiller, the company said Wednesday.

PITTSBURGH — Mylan has launched a generic version of an opioid painkiller, the company said Wednesday.

Mylan announced the launch of oxycodone hydrochloride tablets in the 5-mg, 15-mg and 30-mg strengths. Mylan is launching the drug under a development and supply agreement with Coastal Pharmaceuticals.

The drug is a generic version of Xanodyne’s Roxicodone, a treatment for moderate to severe pain. Oxycodone hydrochloride tablets had sales of about $325 million during the 12-month period ended in March, according to IMS Health.