PHARMACY

Kapvay designed to treat ADHD

BY Alaric DeArment

FLORHAM PARK, N.J. — Drug maker Shionogi has launched a new medication for attention deficit hyperactivity disorder, the company said Monday.

Shionogi announced the launch of Kapvay (clonidine hydrochloride), an extended-release drug for treating ADHD in children and adolescents. The company said the drug was the only ADHD treatment approved as an add-on to stimulant medications, though it can be used alone as well.

“Shionogi is extremely proud to bring Kapvay to market in the United States,” Shionogi chief medical officer Donald Manning said. “The extended-release version of clonidine hydrochloride found in Kapvay offers an exciting new treatment option for children and adolescents with ADHD who are not experiencing adequate symptom relief from stimulants alone.”

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PHARMACY

PakSense introduces BIOmed Label

BY Alaric DeArment

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.”

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Endo receives complete response letter for crush-resistant Opana ER

BY Alaric DeArment

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.

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