Content about Opioids

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

NEW YORK — The Food and Drug Administration has declined to approve an investigative painkiller made by Pfizer, the drug maker said Friday.

The FDA issued a complete response letter for Remoxy (oxycodone) extended-release capsules, which Pfizer is developing under a partnership with Pain Therapeutics. Pain Therapeutics originally developed the drug using Durect’s Oradur technology, which is designed to prevent tampering by drug abusers, in collaboration with King Pharmaceuticals. Pfizer took control of development of the drug when it acquired King in February.

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.