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Latest From Apotex Inc.

Apotex And Ambio Shatter Hopes Of Teriparatide Exclusivity For Teva

Partners Apotex and Ambio have announced approval of a second US teriparatide generic from the FDA, adding another Forteo rival to the market and removing hopes that Teva’s recently approved first generic could benefit from 180 days of market exclusivity. Further competition is also in the works with Amphastar awaiting FDA action on a further teriparatide ANDA.

Approvals Generic Drugs

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
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Pharmaceuticals
    • Drug Delivery
    • Generic Drugs
    • Nutraceuticals
  • Biotechnology
    • Drug Discovery Tools
      • Molecular Diversity
        • Natural Products
  • Other Names / Subsidiaries
    • Apobiologix
    • 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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