Content about Analgesics

July 5, 2012
FDA orders unapproved oxycodone drugs off market

The Food and Drug Administration is asking companies to stop manufacturing and distributing unapproved drugs containing the painkiller oxycodone, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration is asking companies to stop manufacturing and distributing unapproved drugs containing the painkiller oxycodone, the agency said Thursday.

June 28, 2012
APhA introduces acetaminophen continuing-education program for pharmacists

A new continuing-education program offered by a national pharmacist professional organization aims to prepare pharmacists to communicate with patients about the safe and effective use of the painkiller acetaminophen.

WASHINGTON — A new continuing-education program offered by a national pharmacist professional organization aims to prepare pharmacists to communicate with patients about the safe and effective use of the painkiller acetaminophen.

The American Pharmacists Association said its new CE program would allow pharmacists to outline the Food and Drug Administration's recent advisory panel meetings on the drug, communicate with patients about its appropriate use, and engage consumers in dialogue and such activities as reading labels of products containing acetaminophen.

June 20, 2012
NACDS urges Congress to pass PDUFA as final congressional vote nears

The National Association of Chain Drug Stores on Wednesday urged Congress to pass the Prescription Drug User Fee Act, legislation essential to the review process for new medications and that also contains important pro-patient, pro-pharmacy provisions.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores on Wednesday urged Congress to pass the Prescription Drug User Fee Act, legislation essential to the review process for new medications and that also contains important pro-patient, pro-pharmacy provisions.

The U.S. House and Senate passed their versions of PDUFA last month and worked to reconcile their individual bills into one final bill. Both chambers are expected to vote on the final conference report this week.

June 1, 2012
Pharmacy groups oppose hydrocodone amendment to PDUFA bill

Five pharmacy organizations on Thursday wrote Congress in opposition of an amendment to the Food and Drug Administration Safety Innovation Act due to its potential to delay patients' timely relief from chronic pain while increasing drug costs.

ALEXANDRIA,Va. — Five pharmacy organizations on Thursday wrote Congress in opposition of an amendment to the Food and Drug Administration Safety Innovation Act due to its potential to delay patients' timely relief from chronic pain while increasing drug costs.
 

May 7, 2012
Purdue Pharma launches free educational resource to combat drug abuse

Drug maker Purdue Pharma has introduced a new educational resource for healthcare professionals designed to curb the abuse of prescription drugs, the company said Monday.

STAMFORD, Conn. — Drug maker Purdue Pharma has introduced a new educational resource for healthcare professionals designed to curb the abuse of prescription drugs, the company said Monday.

March 27, 2012
HIE, mobile technology dominate conversations at HIMSS

A few weeks ago, we joined some 37,000 of our closest friends for the Healthcare Information and Management Systems Society (HIMSS) annual conference. HIMSS is a cause-based, not-for-profit organization focused on providing global leadership for the optimal use of information technology (IT) and management systems for the betterment of health care.

A few weeks ago, we joined some 37,000 of our closest friends for the Healthcare Information and Management Systems Society (HIMSS) annual conference. HIMSS is a cause-based, not-for-profit organization focused on providing global leadership for the optimal use of information technology and management systems for the betterment of health care.

March 5, 2012
Hisamitsu America launches trio of topical pain relief solutions

Hisamitsu America on Monday launched three new analgesic patches, the company stated.

FLORHAM PARK, N.J. — Hisamitsu America on Monday launched three new topical analgesic solutions, the company stated.

February 17, 2012
McNeil recalls Infant's Tylenol over package design flaw

McNeil Consumer Healthcare on Friday issued a voluntary recall, at the wholesale and retail levels, of seven lots of Infants' Tylenol oral suspension 1-oz. grape that was distributed nationwide over consumer complaints of the included dosing system.

FORT WASHINGTON, Pa. — McNeil Consumer Healthcare on Friday issued a voluntary recall, at the wholesale and retail levels, of seven lots of Infants' Tylenol oral suspension 1-oz. grape that was distributed nationwide over consumer complaints of the included dosing system.

McNeil's Infants' Tylenol SimpleMeasure includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or “flow restrictor,” at the top of the bottle to measure the proper dose. In some cases, the flow restrictor was pushed into the bottle when inserting the syringe.

February 15, 2012
Prescription drug monitoring programs: Keeping good drugs from going bad
Regulators, healthcare providers and the public at large have taken note of the rise in prescription drug substance abuse. A recent article titled "Oxycodone Prescriptions Rose Sharply" in the New York Times (1/11/2012) describes trends of double-digit percentage increases in the dispensing of certain narcotic based painkillers. And many states have, or will be, implementing prescription drug monitoring programs — also known as prescription monitoring programs — that track the physicians prescribing and the patients receiving controlled substances.

Regulators, healthcare providers and the public at large have taken note of the rise in prescription drug substance abuse. A recent article titled "Oxycodone Prescriptions Rose Sharply" in the New York Times (1/11/2012) describes trends of double-digit percentage increases in the dispensing of certain narcotic based painkillers.

February 7, 2012
Investigational Merck drug 'significantly' reduces cardiovascular death

A drug under development by Merck "significantly" reduced the risk of heart attack, stroke and cardiovascular death in patients, according to clinical trial results announced Tuesday.

WHITEHOUSE STATION, N.J. — A drug under development by Merck "significantly" reduced the risk of heart attack, stroke and cardiovascular death in patients, according to clinical trial results announced Tuesday.

January 27, 2012
Watson, Mallinckrodt settle over generic painkiller

Watson Pharmaceuticals and Mallinckrodt have reached a settlement concerning a painkiller for which the former had sought Food and Drug Administration approval.

PARSIPPANY, N.J. — Watson Pharmaceuticals and Mallinckrodt have reached a settlement concerning a painkiller for which the former had sought Food and Drug Administration approval.

January 9, 2012
Endo addresses possible short-term supply of Opana ER, other drugs

Endo Pharmaceuticals announced a short-term supply constraint of analgesic products, including Opana ER, due to the temporary shutdown of a manufacturing facility operated by Novartis Consumer Health.

CHADDS FORD, Pa. — Endo Pharmaceuticals announced a short-term supply constraint of analgesic products, including Opana ER, due to the temporary shutdown of a manufacturing facility operated by Novartis Consumer Health.

January 3, 2012
FDA approves new REMS for fentanyl-based painkillers

The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said Tuesday.

December 23, 2011
FDA warns parents to read drug facts label for liquid APAP

The Food and Drug Administration on Thursday urged consumers to carefully read the labels of liquid acetaminophen marketed for infants to avoid giving the wrong dose to their infants.

SILVER SPRING, Md. — The Food and Drug Administration on Thursday urged consumers to carefully read the labels of liquid acetaminophen marketed for infants to avoid giving the wrong dose to their infants. Giving more than the recommended dose of acetaminophen can cause serious side effects and possibly death, the agency warned.

December 22, 2011
Actavis, QRxPharma partner to sell MoxDuo IR

Drug maker Actavis is partnering with QRxPharma to sell what the former called a novel pain drug in the United States.

MORRISTOWN, N.J. — Drug maker Actavis is partnering with QRxPharma to sell what the former called a novel pain drug in the United States.

The company said Wednesday that the two had signed a letter of intent to commercialize MoxDuo IR (morphine and oxycodone), which they plan to launch in third quarter 2012.

December 22, 2011
Pfizer announces Embeda post-market trial results

A Pfizer painkiller appears to produce a much less positive experience for recreational drug users when crushed than when administered whole, according to results of a post-marketing clinical study program.

NEW YORK — A Pfizer painkiller appears to produce a much less positive experience for recreational drug users when crushed than when administered whole, according to results of a post-market clinical study program.

December 15, 2011
DXM abuse down among high school seniors; overall Rx and Vicodin abuse up

Approximately 5.3% of high school seniors abused over-the-counter cough-cold medicines in the past month, according to the latest "Monitoring the Future" survey released Wednesday by the National Institute on Drug Abuse.

WASHINGTON — Approximately 5.3% of high school seniors abused over-the-counter cough-cold medicines in the past month, according to the latest "Monitoring the Future" survey released Wednesday by the National Institute on Drug Abuse. That's down from 6.6% of high school seniors who claimed to have recently abused cough-cold medicines last year.

December 13, 2011
Report: New Wash. law cuts off patient access to painkillers

A new law in Washington state intended to curb accidental deaths related to opioid painkillers is having some adverse side effects, according to published reports.

NEW YORK — A new law in Washington state intended to curb accidental deaths related to opioid painkillers is having some adverse side effects, according to published reports.

December 12, 2011
FDA approves crush-resistant painkiller by Endo

The Food and Drug Administration has approved a new formulation of a painkiller made by Endo Pharmaceuticals designed to thwart drug abuse, Endo said Monday.

CHADDS FORD, Pa. — The Food and Drug Administration has approved a new formulation of a painkiller made by Endo Pharmaceuticals designed to thwart drug abuse, Endo said Monday.

Endo announced the FDA's approval of a crush-resistant version of Opana ER (oxymorphone). Drug abusers often crush opioid pills in order to smoke, inhale or inject them. Endo developed the new formulation of the drug, scheduled for launch in 2012, using Grunenthal's Intac technology. The new version will otherwise be identical to the old one.

December 12, 2011
FDA approves painkiller made by Sun Pharmaceutical Industries

The Food and Drug Administration has approved a generic painkiller made by Sun Pharmaceutical Industries, Sun said.

MUMBAI, India — The Food and Drug Administration has approved a generic painkiller made by Sun Pharmaceutical Industries, Sun said.

Sun announced the approval of tramadol hydrochloride extended-release tablets, a generic version of Valeant International's Ultram ER. The drug is used to treat moderate to moderately severe chronic pain in adults who need constant treatment for an extended period of time.

Various versions of the drug have annual sales of $125 million, according to Sun.

December 1, 2011
APAP suppository FeverAll returns to store shelves

Actavis is in the process of bringing FeverAll acetaminophen suppositories back to the market, the company announced. FeverAll had been unavailable while changes were being made at the product's manufacturing facility.

MORRISTOWN, N.J. — Actavis is in the process of bringing FeverAll acetaminophen suppositories back to the market, the company announced. FeverAll had been unavailable while changes were being made at the product's manufacturing facility.

November 21, 2011
Impax Labs looks to market generic cancer pain drug

Drug maker Impax Labs is looking to challenge the patent protection on a drug used to treat pain related to cancer, the company said Monday.

HAYWARD, Calif. — Drug maker Impax Labs is looking to challenge the patent protection on a drug used to treat pain related to cancer, the company said Monday.

Impax said it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Cephalon's Fentora (fentanyl) buccal tablets in the 100 mcg, 200 mcg, 400 mcg, 600 mcg and 800 mcg strengths. The drug is used to treat breakthrough cancer pain, defined as pain related to cancer that can't be controlled by other drugs.

November 15, 2011
Actavis launches Kadian authorized generic

Actavis has launched an authorized generic drug for treating pain, the company said.

MORRISTOWN, N.J. — Actavis has launched an authorized generic drug for treating pain, the company said.

The drug maker announced Friday that it had started shipping morphine sulfate extended-release capsules, an authorized generic version of Kadian, which it also manufactures. The authorized generic product was launched on the same day as Watson Pharmaceuticals' generic version.

November 14, 2011
FDA approves Qualitest painkiller

The Food and Drug Administration has approved a generic drug for treating pain.

HUNTSVILLE, Ala. — The Food and Drug Administration has approved a generic drug for treating pain.

Qualitest Pharmaceuticals announced Monday the approval of acetaminophen and codeine phosphate oral solution in the 120-mg/12-mg-per-5-mL strength.

Sales for acetaminophen and codeine phosphate oral solution for $4.3 million during the 12-month period ended in September, according to IMS Health.

November 11, 2011
Watson launches generic painkiller

Watson Pharmaceuticals has launched its generic version of an opioid drug for treating pain, the company said Thursday.

PARSIPPANY, N.J. — Watson Pharmaceuticals has launched its generic version of an opioid drug for treating pain, the company said Thursday.

Watson announced the Food and Drug Administration approval and launch of morphine sulfate extended-release capsules.

The drug is a generic version of Actavis' Kadian, which had sales of about $275 million during the 12-month period ended in September, according to IMS Health.