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Genentech human growth hormone

Executive Summary

Representatives from the biotech company met with FDA officials Feb. 3 seeking "notification in advance of the approval of any non-Genentech recombinant DNA human growth hormone," according to FDA minutes of the meeting. The meeting was a followup to Genentech's Nov. 3 petition to FDA requesting the establishment of procedural safeguards for sponsors of orphan drugs, including a notice and comment period before any variants of orphan drug products are approved. The petition also maintained that Genentech's Protropin is entitled to market exclusivity from second generation human growth hormones because it is "clinically equivalent" to second generation products under development ("The Pink Sheet" Nov. 17, p. 11).
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PS011469

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