PHARMACY

Dey Pharma launches MyEpiPen app

BY Alaric DeArment

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.”

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Under PEPFAR, Matrix gets tentative approval for generic Combivir

BY Alaric DeArment

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.

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MannKind receives complete response letter for Afrezza

BY Allison Cerra

VALENCIA, Calif. — It seems that MannKind has experienced a setback with a drug designed to control hyperglycemia in Type 1 and Type 2 diabetes patients.

The Food and Drug Administration on Thursday issued a complete response letter to the drug maker regarding Afrezza (insulin human [rDNA origin]) inhalation powder. The regulatory agency requested that the company conduct two clinical trials, one in patients with Type 1 diabetes and one in patients with Type 2 diabetes, with its next-generation inhaler, to assure it works as effectively as MedTone, its predecessor.

"While we are disappointed with the complete response letter, we are encouraged that the FDA is asking for clinical studies only to confirm the bridging and handling of the next-generation device in order to compare it to the device used in our extensive clinical program," said MannKind’s chairman and CEO Alfred Mann. "We remain committed to working with the FDA to make Afrezza available to people with diabetes."

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