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Under PEPFAR, Matrix granted tentative approval for novel co-packaged HIV/AIDS treatment

BY Allison Cerra

PITTSBURGH — Mylan subsidiary Matrix Labs has received tentative approval from the Food and Drug Administration for its new drug application of a co-packaged antiretroviral treatment under the President’s Emergency Plan for AIDS Relief.

Matrix said that lamivudine/tenofovir disoproxil fumarate tablets in the 300-mg/300-mg strength, co-packaged with nevirapine tablets in the 200-mg strength, would be eligible for purchase outside of the United States in certain developing countries. Lamivudine, tenofovir disoproxil fumarate and nevirapine are the generic versions of GlaxoSmithKline’s Epivir, Gilead Sciences’ Viread and Boehringer Ingelheim’s Viramune, respectively.

"The approval of lamivudine/tenofovir disoproxil fumarate tablets co-packaged with bevirapine tablets is an important product developed by Matrix for the treatment of HIV/AIDS," Mylan president Heather Bresch said. "For the first time, it makes available a co-pack option that can help patients with the carrying and storage of this critical first-line ARV cocktail. Co-packs are convenient and may help to facilitate patient compliance with what often can be part of a burdensome drug regimen for HIV/AIDS patients managing many prescriptions and therapies."

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Watson, Amphastar get go-ahead for generic Lovenox

BY Allison Cerra

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic version of a deep vein thrombosis treatment.

Watson Pharmaceuticals said that Amphastar Pharmaceuticals’ abbreviated new drug application for enoxaparin sodium injection in the 100-mg/mL and 150-mg/mL strengths received approval from the FDA. Enoxaparin sodium injection is the generic equivalent of Sanofi’s Lovenox.

The generic drug development is part of Watson and Amphastar’s exclusive distribution agreement, whereby Amphastar will supply generic Lovenox to Watson, which will market, sell and distribute the product to the U.S. retail pharmacy channel. Additionally, Amphastar will receive between 50% and 55% of Watson’s gross profits on product sales, depending on the number of competitors in the market.

Lovenox and its generic equivalents had total U.S. sales of approximately $2.6 billion, according to IMS Health data.

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Fighting fire with fire: ESI, Medco debut ad

BY Allison Cerra

WASHINGTON — One day after the National Association of Chain Drug Stores launched a radio ad in the Washington, D.C., market that warned of the potential consequences of the merger between pharmacy benefit managers Express Scripts and Medco, the PBMs have debuted their own ad, which seeks to highlight the benefits of the deal.

The ad, which will be displayed across several publications Tuesday and Wednesday, including Roll Call, CQ, Politico and others, said the deal will drive out wasteful spending, lower costs for consumers, improve health outcomes and increase safety and affordability. "At no time in the history of American healthcare has there been a greater need for innovation," the ad reads. "By working together, Express Scripts and Medco can accelerate their unique abilities to improve patient care. Moving forward as one company, we’ll continue doing what’s right for America."

A congressional hearing pertaining to the merger is expected to be held this week. Earlier this month, the Federal Trade Commission requested additional information on the merger via a "second request."

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