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Latest From Apotex Inc.

Vanda Launches Barrage Of Suits Against FDA Seeking To Retain Hetlioz Market

In 17 suits against FDA in the last two years, firm seeks to block generics of its sleep-wake disorder drug and gain a jet lag indication. CEO Mihael Polymeropoulos tells the Pink Sheet that FDA has retaliated against Vanda for its first suit challenging a partial clinical hold on another drug.

FDA Drug Approval Standards

Teva Clears Another Overhang With US Price-Fixing Settlement

The settlement closes a multi-year investigation by the US Department of Justice into generic drug price fixing schemes that involved charges against seven companies.

Generic Drugs Legal Issues

Cancer Drug ‘Strategic Reserve’ May Be Shortage Solution, US FDA’s Pazdur Says

A national stockpile could provide immediate relief in the case of shortages, but also a ‘floor’ under pricing that might prevent more shortages in the first place, the head of the US FDA’s Oncology Center of Excellence says.

Cancer Manufacturing

Generic Hetlioz Does Not Require Braille Labeling, FDA Tells Vanda

FDA says Teva and Apotex’s generic products do not violate the ‘same labeling’ requirement because they were produced by different manufacturers and that braille is not necessary for safe and effective use of tasimelteon products. Vanda's generic labeling suit against the FDA remains pending.

Generic Drugs Legal Issues
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