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Latest From Apotex Inc.
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.
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.
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.
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.
- Drug Delivery
- Generic Drugs
Drug Discovery Tools
- Natural Products
- Molecular Diversity
- Drug Discovery Tools
- Other Names / Subsidiaries
- ApoPharma, Inc.
- Apotex Australia
- Arrow Pharmaceuticals Pty Ltd.
- Arrow Remedies Private Limited
- Arrotex Australia Group Pty Ltd
- Aveva Drug Delivery Systems, Inc.
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