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August 15, 2012
Codeine increases risk of death in some children, FDA warns

Children who take a class of opioid pain relievers after certain surgeries may be at risk of death, the Food and Drug Administration warned Wednesday.

SILVER SPRING, Md. — Children who take a class of opioid pain relievers after certain surgeries may be at risk of death, the Food and Drug Administration warned Wednesday.

The FDA issued the warning after receiving reports of three children who died and one who experienced a life-threatening case of respiratory depression after taking codeine following tonsil- and adenoid-removal surgery.

August 8, 2012
FDA approves morphine sulfate oral solution

The Food and Drug Administration has approved an oral painkiller made by Perrigo, the drug maker said Wednesday.

ALLEGAN, Mich. — The Food and Drug Administration has approved an oral painkiller made by Perrigo, the drug maker said Wednesday.

Perrigo announced the approval of morphine sulfate oral solution in the 100-mL/5% strength. The drug is a Schedule II controlled substance and is used to treat moderate to severe acute and chronic pain. Sales of the drug are about $26 million per year, according to Wolters Kluwer Health. Perrigo said it would ship the drug immediately.

July 16, 2012
FDA accepts opioid drug application from Zogenix

The Food and Drug Administration has accepted a regulatory application for an opioid painkiller made by Zogenix, the company said Monday.

SAN DIEGO — The Food and Drug Administration has accepted a regulatory application for an opioid painkiller made by Zogenix, the company said Monday.

The drug maker announced the FDA's acceptance of its application for Zohydro (hydrocodone bitartrate) extended-release capsules, designed for moderate to severe chronic pain. The company expects the FDA to decide whether or not to approve the drug by March 1, 2013.

July 16, 2012
Rx drug abuse rises in high school students

Several policy-makers and companies have sought ways to confront the problem of prescription drug abuse. Last month, New York Gov. Andrew Cuomo announced a plan — calling it the first in the country — to create an all-
electronic registry that would enable doctors, pharmacists and law enforcement to track controlled substances to prevent excessive prescription and refill requests.

News broke last month that officials in the South American nation of Uruguay were planning to possibly legalize marijuana. Meanwhile, activists in Colorado have sought to legalize the drug in that state, while Chicago’s city council decriminalized possession of small amounts of marijuana and reduced the penalty to a ticket.


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 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.

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.

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.

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 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.

November 8, 2011
Purdue Pharma launches RxPATROL Twitter feed

Purdue Pharma has launched a new way for fighting pharmacy crime, the drug maker said Tuesday.

STAMFORD, Conn. — Purdue Pharma has launched a new way for fighting pharmacy crime, the drug maker said Tuesday.

October 27, 2011
Mylan gets green light for MS Contin generic

Mylan has received final approval from the Food and Drug Administration for a drug designed to treat moderate to severe pain.

PITTSBURGH — Mylan has received final approval from the Food and Drug Administration for a drug designed to treat moderate to severe pain.

Mylan said its abbreviated new drug application for morphine sulfate extended-release tablets in the 15-mg, 30-mg, 60-mg, 100-mg and 200-mg strengths was approved by the FDA. The opioid analgesic is a generic version of Purdue Pharma's MS Contin. Mylan said it is launching the product immediately.

Morphine sulfate ER tablets had U.S. sales of approximately $173 million for the 12 months ended in June, according to IMS Health.

October 7, 2011
Watson files for approval of generic painkiller

Watson Pharmaceuticals is looking to become the first to market a generic version of a painkiller made by Pfizer, the drug maker said Friday.

PARSIPPANY, N.J. — Watson Pharmaceuticals is looking to become the first to market a generic version of a painkiller made by Pfizer, the drug maker said Friday.

Watson said it filed a regulatory approval application with the Food and Drug Administration for morphine sulfate and naltrexone hydrochloride extended-release capsules in the 30-mg/1.2-mg, 50-mg/2-mg, 60-mg/2.4-mg, 80-mg/3.2-mg and 100-mg/4-mg strengths. The drug is a generic version of Embeda, made by Pfizer subsidiary King Pharmaceuticals.

October 4, 2011
Amneal launches generic Felbatol

Amneal last month launched its version of an epilepsy treatment.

BRIDGEWATER, N.J. — Amneal last month launched its version of an epilepsy treatment.

The drug maker said that felbamate tablets are available in 400-mg and 600-mg strengths, following approval from the Food and Drug Administration last month. The drug is the first-to-market generic equivalent of Meda Pharmaceuticals' Felbatol, Amneal said.

The Amneal generic is available in 90-count bottles in 400-mg strength and 90- and 180-count sizes in 600-mg strength, the company said.

Annual U.S. sales of Felbatol totaled $43.7 million, according to IMS Health data.

August 12, 2011
Lannett ships morphine product

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 2, 2011
FDA approves Covidien painkiller

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 20, 2011
Purdue launches RxSafetyMatters.org

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
QRxPharma seeks FDA approval for MoxDuo IR

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.

June 24, 2011
FDA accepts Endo's resubmission for Opana ER

The Food and Drug Administration has accepted a resubmission by Endo Pharmaceuticals of a regulatory application for an opioid pain drug designed to thwart abuse, Endo said.

CHADDS FORD, Pa. — The Food and Drug Administration has accepted a resubmission by Endo Pharmaceuticals of a regulatory application for an opioid pain drug designed to thwart abuse, Endo said.

The agency had declined to approve Endo’s Opana ER (oxymorphone hydrochloride) in January for reasons that the company did not specify, though the agency did not request additional clinical studies in its statement, known as a complete response letter.

June 22, 2011
Pfizer, Acura get FDA OK for Oxecta

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.