Content about Piperidines

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.

NEW YORK — A new drug for treating attention deficit hyperactivity disorder made by Pfizer is now available, the drug maker said.

Pfizer announced the availability of Quillivant XR (methylphenidate hydrochloride) extended-release oral suspension, calling it the first once-per-day, extended-release liquid formulation of methylphenidate. The Food and Drug Administration approved the drug in September 2012.

HAYWARD, Calif. — Two generic drug makers have settled with a subsidiary of Johnson & Johnson and another company concerning a drug used to treat attention deficit hyperactivity disorder.

Impax Labs and Teva Pharmaceuticals USA had settled a patent infringement suit with Janssen Pharmaceuticals and Alza over Concerta (methylphenidate hydrochloride) extended-release tablets in the 18-mg, 27-mg, 36-mg and 54-mg strengths.

INDUSTRY NEWS — Manufacturers of sunscreen now will have six additional months to meet the new labeling and testing requirements as imposed by the Food and Drug Administration, according to an announcement from the Federal Register. The FDA ordered the changes last summer but gave manufacturers one year — until this June — to get the revised bottles on the shelf. The FDA now is delaying the compliance dates of the 2011 final rule by six months, to Dec. 17 for products with sales of $25,000 or more; and until Dec.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic version of a drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Wednesday.

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.

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.

ALLEGAN, Mich. — The Food and Drug Administration has approved a generic version of Rogaine made by Perrigo, the drug maker said.

Perrigo announced the FDA approval of over-the-counter minoxidil foam, a generic version of men’s Rogaine foam.

Stiefel Research Australia, part of GlaxoSmithKline, sued Perrigo for patent infringement when the latter submitted its regulatory approval application. Under a settlement between the companies reached in February, Perrigo can launch its generic version of men’s Rogaine foam in March 2012.

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.

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.

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.

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.