Content about Fentanyl

October 28, 2013

Depomed has launched a new drug for breakthrough pain in cancer patients, the company said Monday.

NEWARK, Calif. — Depomed has launched a new drug for breakthrough pain in cancer patients, the company said Monday.

The drug maker announced the launch of Lazanda (fentanyl) nasal spray, meant for treating adults who are taking opioid painkillers, but have become tolerant to them. The company also have launched a Signature Support Program designed to streamline patient access to the drug, including reimbursement and co-pay assistance. Other benefits of the program include prescription reminders and eligibility for one month's supply for free.

October 3, 2013

The Food and Drug Administration is requiring Johnson & Johnson to use long-lasting ink in the labeling and dosage strength of an opioid painkiller patch it markets in order to make it easier to see.

SILVER SPRING, Md. — The Food and Drug Administration is requiring Johnson & Johnson to use long-lasting ink in the labeling and dosage strength of an opioid painkiller patch it markets in order to make it easier to see.

July 8, 2013

Nearly 30 children have been accidentally poisoned by opioid painkiller patches since 1997, according to the Food and Drug Administration, prompting the agency to issue disposal guidelines.

NEW YORK — Nearly 30 children have been accidentally poisoned by opioid painkiller patches since 1997, according to the Food and Drug Administration, prompting the agency to issue disposal guidelines.

The FDA listed the guidelines on its website, saying that unused fentanyl patches should be stored out of the reach and sight of children, while used patches should be folded, sticky sides together, and flushed down the toilet.

March 18, 2013

Galena Biopharma has purchased rights to a treatment for breakthrough cancer pain from a Swedish drug maker, Galena said Monday.

LAKE OSWEGO, Ore. — Galena Biopharma has purchased rights to a treatment for breakthrough cancer pain from a Swedish drug maker, Galena said Monday.

Galena, which specializes in cancer-related drugs, said it acquired Abstral (fentanyl) sublingual tablets for sale and distribution in the United States from Orexo AB. Breakthrough cancer pain, or BTcP, affects between 40% to 80% of cancer patients, with reported episodes of four per day and a median duration of 30 minutes, according to Galena.

October 16, 2012

Par Pharmaceutical Cos. has entered into agreements with Watson Pharmaceuticals and Actavis to purchase five generic products currently marketed in the United States by Watson or Actavis, eight abbreviated new drug applications currently awaiting regulatory approval, and a generic product in late-stage development.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical Cos. has entered into agreements with Watson Pharmaceuticals and Actavis to purchase five generic products currently marketed in the United States by Watson or Actavis, eight abbreviated new drug applications currently awaiting regulatory approval, and a generic product in late-stage development.

August 23, 2012

A drug maker that specializes in pain medications started the third late-stage trial of a drug for treating pain in patients who have undergone certain surgeries.

REDWOOD CITY, Calif. — A drug maker that specializes in pain medications started the third late-stage trial of a drug for treating pain in patients who have undergone certain surgeries.

January 23, 2012

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

SUPPLIER NEWS — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said. The FDA announced the approval of a single REMS for transmucosal immediate-release fentanyl drugs. The new system, which takes effect in March, will allow prescribers and pharmacies to enroll into one system instead of individual systems for each product.

January 3, 2012

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.

November 21, 2011

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.

October 17, 2011

Archimedes Pharma has launched a new drug for breakthrough cancer pain, the drug maker said Monday.

BEDMINSTER, N.J. — Archimedes Pharma has launched a new drug for breakthrough cancer pain, the drug maker said Monday.

Archimedes announced the launch of Lazanda (fentanyl) nasal spray for adult patients who have developed a tolerance to opioid therapy for persistent, underlying cancer pain. The drug uses Archimedes' patented PecSys delivery system, which allows the drug to be absorbed across the nasal membrane and directly into the bloodstream. The Food and Drug Administration approved the drug on June 30.

October 10, 2011

The Federal Trade Commission has given Teva Pharmaceutical Industries the green light to acquire Frazer, Pa.-based drug maker Cephalon, but with some restrictions, Teva said.

JERUSALEM — The Federal Trade Commission has given Teva Pharmaceutical Industries the green light to acquire Frazer, Pa.-based drug maker Cephalon, but with some restrictions, Teva said.

Before it can complete the $6.8 billion deal, Teva must sell to Par Pharmaceutical Cos. its generic versions of two Cephalon drugs, namely generic versions of the cancer pain drug Actiq (fentanyl citrate) and the muscle relaxant drug Amrix (cyclobenzaprine), which have combined sales of $298 million per year, according to IMS Health.

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.

April 4, 2011

A drug used to treat pain in cancer patients now is available in the United States.

BEDMINSTER, N.J. — A drug used to treat pain in cancer patients now is available in the United States.

ProStrakan Group announced Monday the launch of Abstral (fentanyl) sublingual tablets. The tablets, which disintegrate rapidly and are placed under the tongue, treat breakthrough pain, common in one-half to two-thirds of people with cancer-related pain.

The drug, an opioid and controlled substance, only is available through a Food and Drug Administration-mandated REMS program. The FDA approved the drug in January.

March 30, 2011

Canadian drug maker Valeant Pharmaceuticals has proposed to buy Cephalon for $5.7 billion, Valeant said Tuesday.

MISSISSAUGA, Ontario — Canadian drug maker Valeant Pharmaceuticals has proposed to buy Cephalon for $5.7 billion, Valeant said Tuesday.

The buyout offer, equal to $73 per share, includes a 29% premium over Cephalon’s stock price. Valeant noted it had made previous offers, but was “disappointed by Cephalon’s unwillingness to engage in discussions in a timely manner.”

March 25, 2011

A generic painkiller made by Watson Pharmaceuticals infringes a patent covering the branded version, a U.S. District Court ruled.

MORRISTOWN, N.J. — A generic painkiller made by Watson Pharmaceuticals infringes a patent covering the branded version, a U.S. District Court ruled.

Watson said Friday that the U.S. District Court for the District of Delaware decided that Watson’s generic version of Cephalon’s Fentora (fentanyl) buccal tablets infringes U.S. Patent No. 6,264,981, though the Food and Drug Administration had approved Watson’s version of the drug.

March 15, 2011

A generic painkiller made by Watson Pharmaceuticals does not infringe on the patent covering the branded version, a U.S. District Court has ruled.

MORRISTOWN, N.J. — A generic painkiller made by Watson Pharmaceuticals does not infringe on the patent covering the branded version, a U.S. District Court has ruled.

Watson said the U.S. District Court for the District of Delaware ruled that Watson’s generic version of Cephalon’s Fentora (fentanyl buccal tablets) does not infringe on two patents that were set to expire in March 2019, according to Food and Drug Administration records.

February 11, 2011

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

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.

January 20, 2011

British drug maker ProStrakan Group will partner with two U.S. companies to administer its risk evaluation and mitigation strategy for a cancer pain drug.

ATLANTA — British drug maker ProStrakan Group will partner with two U.S. companies to administer its risk evaluation and mitigation strategy for a cancer pain drug.

ProStrakan said it would use RelayHealth Pharmacy Solutions’ and McKesson Specialty Care Solutions’ services to administer the REMS for Abstral (fentanyl citrate), a drug that patients can place under the tongue to treat breakthrough pain associated with cancer when they already have received and become tolerant of opioid painkillers.

January 10, 2011

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

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.

January 10, 2011

The Food and Drug Administration has approved a generic drug made by Watson Pharmaceuticals for cancer-related pain, Watson said Monday.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug made by Watson Pharmaceuticals for cancer-related pain, Watson said Monday.

Watson announced the approval of fentanyl buccal tablets in the 0.1-mg, 0.2-mg, 0.6-mg and 0.8-mg strengths.

October 25, 2010

Actavis last week recalled 18 lots of its patches designed to treat persistent, moderate to...

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

August 22, 2010

British drug maker Archimedes Pharma plans to set up its U.S. headquarters in New Jersey,...

June 23, 2010

The Food and Drug Administration has given tentative approval to Watson Pharmaceuticals for a generic...