ProStrakan taps two companies to administer REMS program for Abstral
ATLANTA — British drug maker ProStrakan Group will partner with two U.S. companies to administer its risk evaluation and mitigation strategy for a cancer pain drug.
ProStrakan said it would use RelayHealth Pharmacy Solutions’ and McKesson Specialty Care Solutions’ services to administer the REMS for Abstral (fentanyl citrate), a drug that patients can place under the tongue to treat breakthrough pain associated with cancer when they already have received and become tolerant of opioid painkillers.
“RelayHealth’s innovative connectivity technologies in pharmacies and McKesson Specialty Care Solutions’ deep REMS experience is an excellent fit for our Abstral REMS program,” ProStrakan president for global commercial operations Abid Karim said.
Dey Pharma launches MyEpiPen app
BASKING RIDGE, N.J. — Mylan subsidiary Dey Pharma has launched a mobile application for patients at risk of severe allergic reactions, which is tied to its EpiPen product.
The MyEpiPen app is available for the Apple iPhone, iPod Touch and iPad, and allows individuals, parents, guardians and others to create and share profiles of severe allergies with friends, family, teachers, school nurses, babysitters and others. Other features include an instructional video, user guide and others.
“Mylan and Dey Pharma have been steadfast in our long-standing commitment to meeting unmet needs,” Dey COO Lloyd Sanders said. “Toward that effort, we are very excited about the MyEpiPen apps, as they will provide a portable and accessible tool to equip individuals and caregivers with valuable information they may need to care for themselves and others in the event of an allergic emergency.”
Under PEPFAR, Matrix gets tentative approval for generic Combivir
PITTSBURGH — The Food and Drug Administration has given tentative approval to an antiretroviral treatment for children with HIV and AIDS under the President’s Emergency Plan for AIDS Relief program.
Mylan announced Thursday that its subsidiary, Matrix Labs, had received the tentative approval for lamivudine and zidovudine tablets in the 30-mg/60-mg strength. The drug is a generic version of Combivir, made by ViiV Healthcare, a company specializing in HIV and AIDS created as a partnership between Pfizer and GlaxoSmithKline.
“The approval of lamivudine and zidovudine is particularly important because it makes available an innovative [fixed-dose combination] treatment option for children who are living with HIV/AIDS in developing countries,” Mylan president Heather Bresch said.