FDA approves injectable morphine product from BD
FRANKLIN LAKES, N.J. — The Food and Drug Administration has approved a new injectable painkiller made by Becton, Dickinson and Co., the medical products manufacturer said Monday.
BD announced the FDA approval of morphine sulfate injection as part of its BD Simplist line of ready-to-administer pre-filled injectables. The drug was approved in the 2-mg-per-mL, 4-mg-per-mL, 5-mg-per-mL, 8-mg-per-mL and 10-mg-per-mL strengths.
"The launch of an FDA-approved morphine product at a time of heightened need is an important step in our plans to drive clinical practice improvements," BD Rx president Mark Sebree said. "The expansion of the BD Simplist product line demonstrates our commitment to providing our hospital and surgical center customers with drugs in high demand today."
The latest approval is the fourth in a series of 20 to 30 drugs BD plans to launch under the BD Simplist brand. The morphine sulfate injection product will hit the market in early 2014.
FDA asks Ariad Pharmaceuticals to suspend sales, marketing of Iclusig amid side-effect concerns
SILVER SPRING, Md. — The Food and Drug Administration has asked Ariad Pharmaceuticals to suspend marketing and sales of a chemotherapy drug for leukemia due to the risk of life-threatening side effects, the agency said.
The FDA issued a notification concerning the drug Iclusig (ponatinib), saying it had found an increased frequency of life-threatening blood clots and severe narrowing of blood vessels in patients taking the drug since its December 2012 approval. Patients taking the drug should discuss with their providers the risks and benefits of continuing treatment with it.
"We will continue to evaluate the drug to further understand its risks and potential patient populations in which the benefits of the drug may outweigh the risks," FDA Division of Drug Information pharmacist Sadhna Khatri said in a podcast on the FDA website.
The agency said Ariad had agreed to the request and recommended that patients taking Iclusig and not responding stop taking it and discuss alternative treatment options; that patients taking the drug and responding discuss it with their providers; and that prescribers not start treating new patients with it unless there are no other treatment options available and all other therapies have failed.
Drug for hypertension in children launched
DENVER — Silvergate Pharmaceuticals has launched a new drug for treating high blood pressure in children, the company said Monday.
The drug maker announced the availability of Epaned (enalapril maleate) powder for oral suspension, for treating hypertension in patients older than 1 month. Enalapril is one of the most commonly prescribed medicines in the United States for high blood pressure. Epaned was approved in August 2013 as a flavored liquid solution to appeal to children and others who have difficulty swallowing enalapril tablets.
"We’re pleased to launch Epaned so quickly after receiving FDA approval," Silvergate president and CEO Frank Segrave said. "Silvergate is happy to take the lead in developing FDA-approved medicines for children, an area of drug development that is often overlooked."