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ArtikelThe War Over Lipitor  
Oleh: Eban, Katherine
Jenis: Article from Bulletin/Magazine
Dalam koleksi: Fortune vol. 163 no. 7 (May 2011), page 92-97.
Topik: Generic Drugs; FDA Approval; Negotiations; Fraud
Fulltext: The War Over Lipitor.pdf (43.89KB)
  • Perpustakaan Pusat (Semanggi)
    • Nomor Panggil: FF16.45
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Isi artikelAs of today, Ranbaxy is expected to launch generic atorvastatin calcium, as the Lipitor molecule is formally known, in the US market on November 30. Under federal rules, Ranbaxy would enjoy six (very profitable) months in which it would have the exclusive right to sell it. The problem: The Food and Drug Administration (FDA) has accused Ranbaxy of "a pattern of systemic fraudulent conduct" over a period of years. The result of the uncertainty about Ranbaxy and Lipitor has been market mayhem. In March, Mylan, one of the seven generic-drug makers hoping to sell Lipitor, sued the FDA, alleging that the agency's "indecision" and delay had made planning all but impossible. Meanwhile, Ranbaxy's negotiations to resolve the federal fraud allegations, now three years long, drag on with no end in sight. Among the obstacles: The FDA is insisting on a meaningful settlement, and Ranbaxy is desperate to retain its rights to Lipitor.
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