PakSense introduces BIOmed Label
BOISE, Idaho — PakSense has launched a small device for monitoring the temperatures of medicines, the company said Monday.
PakSense said its BIOmed Label is about the size of a sugar packet and can be used to digitally monitor the temperatures of pharmaceuticals, biologics and vaccines during storage and distribution.
The company said the monitors are different from other similar devices because they read the temperature off the surface of the object to which they’re attached, allowing a closer approximation of the product’s temperature versus general ambient readings. Other features include LEDs that flash if a specified temperature range is breached and the ability to download and graph temperature readings on a computer. The PakSense Wireless Reader will download temperature data within a 300-ft line of sight, or 60 ft if an object is in the way.
“PakSense has brought a truly innovative temperature-monitoring product to the life sciences space,” PakSense CEO David Light said. “Our new class of recorder is fundamentally changing the way temperature monitoring is performed and is helping quality assurance teams extend their reach into virtually all areas of the supply chain.”
Endo receives complete response letter for crush-resistant Opana ER
CHADDS FORD, Pa. — The Food and Drug Administration declined to approve Endo Pharmaceuticals’ regulatory application for a painkiller designed to thwart drug abusers, Endo said Friday.
The drug maker announced that the FDA had given it a complete response letter for its application for a crush-resistant formulation of Opana ER (oxymorphone hydrochloride). The company did not specify the reason for the letter, but said the agency had not requested additional clinical studies. A complete response letter means that the FDA has completed its review of a regulatory application, but questions remain that preclude final approval.
“As a result of ongoing discussions with the FDA, we have begun to address the issue from the complete response letter and will work closely with the agency to finalize our response,” Endo EVP research and development Ivan Gergel said.
Gergel said the company planned to respond to the FDA by mid-year and would expect the review to take six months.
Watson’s generic Fentora gets FDA approval
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.
The drug, used to treat breakthrough pain in patients with cancer, is a generic version of Cephalon’s Fentora, which had sales of around $179 million during the 12-month period ended in November, according to IMS Health. Breakthrough pain refers to flashes of pain that can’t be controlled through normal painkillers.
As the first company to file for approval of a generic version of the drug, Watson is legally entitled to 180 days’ market exclusivity in which to compete directly with the branded version.