Patent Law Practice Center

Tentative FDA Approval for Oral Pediatric HIV Treatment

Mylan Inc. recently announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) for its New Drug Applications (NDAs) for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients. The FDA’s tentative approval through the President’s Emergency Plan for AIDS Relief (PEPFAR), which is a U.S. Government initiative to help save the lives of those suffering from HIV/AIDS around the world, means the formulations meet all of the agency’s quality, safety and efficacy standards. Mylan’s products are expected to be eligible for purchase in early 2015.

The tentative approval follows a 2012 agreement between Mylan, Clinton Health Access Initiative (CHAI) and ViiV Healthcare to transfer the necessary technology and resources to facilitate regulatory authority submission, production and distribution of the new formulation, at low cost, to a total of 115 resource-limited countries including all low-middle  income, least-developed countries and sub-Saharan Africa.

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Did You Know… About Patents and Presidents

By: Gene Quinn (IPWatchdog.com)

Did you know that President George Washington was a big proponent of a patent system? But he certainly was.

In fact, during his very first State of the Union Address, President Washington implored Congress to immediately take action on passing a Patent Act. See Celebrating Presidents Who Advocated for the Patent System. His urging did not go unnoticed. The first Patent Act, the Patent Act of 1790, was signed into law on April 10, 1790, just several months after President Washington asked Congress to take action.

Did you know that President Thomas Jefferson was one of the first three U.S. patent examiners?

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