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Analysis of clinical outcome on a per-protocol basis (n = 434) demonstrated therapeutic equivalence among the three regimens at the TOC visit; in each treatment group, the clinical cure rate was approximately 75%. The first issue included in-depth information on seven new generics, new data on the treatment of hypertension, four pharmaceutical company profiles, and information on therapeutic equivalence. Under the federal Hatch-Waxman Act of 1984, any generic manufacturer may file an Abbreviated New Drug Application with a certification (a "Paragraph IV Certification") challenging the validity or infringement of a patent listed in the FDA's Approved Drug Products With Therapeutic Equivalence Evaluations (the "Orange Book") for a reference listed drug. |
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