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AMGEN INC. v. PRICE et al
Case Number:
1:17-cv-01006
Court:
Nature of Suit:
Judge:
Firms
Companies
Sectors & Industries:
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February 20, 2018
Amgen Seeks To Hold Off Generics In FDA Denial Challenge
Amgen Inc. on Monday asked a D.C. federal judge to order the U.S. Food and Drug Administration to temporarily refrain from approving any generic versions of its blockbuster drug Sensipar while it appeals a recent order that found the agency properly denied pediatric exclusivity for the calcium-control drug.
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January 26, 2018
FDA Must Explain Amgen Exclusivity Denial, Judge Rules
The U.S. Food and Drug Administration may have acted inconsistently when it denied valuable exclusivity for Amgen Inc.'s blockbuster calcium drug Sensipar and must explain its rationale, a D.C. federal judge ruled Friday.
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September 20, 2017
FDA Cherry-Picking Record In Sensipar Case, Amgen Says
Amgen Inc. accused the U.S. Food and Drug Administration Wednesday of limiting evidence in the company's exclusivity bid for blockbuster calcium-control drug Sensipar, prompting a D.C. federal judge to ask that the parties privately solve the stalemate before the case goes forward.
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June 05, 2017
FDA, Amgen Shelve Sensipar Exclusivity Case
The U.S. Food and Drug Administration and Amgen Inc. on Monday halted litigation in D.C. federal court over denied exclusivity for blockbuster calcium-control drug Sensipar after agreeing to see if the dispute could be ironed out through administrative channels.
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May 31, 2017
FDA Assails Amgen's Sensipar Exclusivity Suit
The U.S. Food and Drug Administration on Wednesday assailed a new lawsuit from Amgen Inc. challenging denied exclusivity for blockbuster calcium-control drug Sensipar, calling the suit premature and arguing that Amgen "blames everyone but itself" for the denial.
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May 26, 2017
Amgen Sues FDA Over Exclusivity For Blockbuster Sensipar
The U.S. Food and Drug Administration improperly denied extra exclusivity for Amgen Inc.'s blockbuster calcium-control drug Sensipar despite years of exhaustive research conducted at the agency's request, according to a new lawsuit from Amgen in D.C. federal court.