In Brief: Genentech's Nutropin AQ
Executive Summary
Genentech's Nutropin AQ: Ready-to-use liquid 10 mg/vial injectable form of somatropin approved Dec. 29 for the same growth hormone insufficiency indications as Nutropin. The recombinant human growth hormone product was available previously in a lyophilized form that required reconstitution with bacteriostatic water. The newly-formulated product has a 28-day shelf-life from initial vial entry compared to 14 days for the lyophilized product. Approval of the Nutropin AQ NDA, submitted in November 1994, was based on results of an open-label clinical trial in previously untreated children with growth hormone insufficiency. Genentech will launch Nutropin AQ in the first quarter at the same price as the lyophilized product...
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