FDA approves Covidien painkiller
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.
"FDA approval of this drug represents a key component in palliative care treatment," Covidien CFO and interim president for pharmaceuticals Matthew Harbaugh said. "It is important that we are able to respond to the concerns of the hospice and palliative care community."
Amneal introduces generic versions of four popular drugs
BRIDGEWATER, N.J. — Generic drug maker Amneal has introduced four new drugs to the market, all available in tablet form.
The products, approved by the Food and Drug Administration, include:
Lorazepam tablets, a generic version of anxiety treatment Ativan, are available in 0.5-mg, 1-mg and 2-mg strengths, each offered in 100-, 500- and 1,000-count containers;
Meclizine HCl tablets, a generic version of antihistamine Antivert, are available in 12.5-mg and 25-mg strengths in 100-, 500- and 1,000-count bottles;
Promethazine HCl tablets, the generic equivalent of antihistamine Phenergan, are available in strengths of 12.5 mg in 100-count, 25 mg in 100- and 1,000-count and 50 mg in 100-count bottles; and
Venlafaxine HCl tablets, the generic equivalent of antidepressant Effexor, are available in five strengths: 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg, each in a 90-count bottle.
"We are very pleased with the addition of these four new products to Amneal’s portfolio and our continued aggressive growth," Amneal president Chirag Patel said. "Going forward, the pace will accelerate as we add several new dosage forms, introduce complex and unique products and realize the results of our dramatically expanded [research and development] team."
FDA gives tentative approval to Intelliject device
RICHMOND, Va. — The Food and Drug Administration has given tentative approval to an emergency treatment for severe allergic reactions made by Intelliject, the drug maker said.
The FDA granted the tentative approval to e-cue, an epinephrine auto-injector for allergic reactions, including anaphylaxis. Tentative approval means that a product meets the agency’s conditions for final approval but outside issues prevent it from hitting the market. In this case, King Pharmaceuticals and Meridian Medical Technologies have filed a patent infringement suit against Intelliject, alleging that it infringes on its patent for the EpiPen, also an auto-injector used for allergic reactions.
The company said it was confident the dispute with King and Meridian would be "favorably resolved."