New chemical entity approval

Straterra is the first new chemical entity approved to treat ADHD in over 30 years, and it has major advantages over the stimulant medications in that it has been clinically demonstrated to have no abuse liability. The nonstimulant mechanism of action also appears to come with some caveats in terms of efficacy versus the stimulants. Synthetically, the main challenge within this molecule is installing the chiral center, which is... 

Table 4-2—Mean and Median Effective Patent Life as a Function 01 Sales for New Chemical Entities Approved 1985-89...

Table G-2-Changes in List Price of New Chemical Entities Approved Between 1981 and 1983...

When taking into account the number of new chemical entities approved for each decade, the rale at which new drugs are being withdrawn due to safely concerns has decreased steadily [2]. 

Lead optimization of new chemical entities (NCEs) based on pharmacokinetic behavior plays a major role in modern drug discovery. Despite advancement of drug delivery methods, the oral route remains the most frequent route of administration for approved new drugs. Therefore, during lead optimization it is essential to identify NCEs with sufficient oral absorption predicted using a variety of in vitro and in vivo assays. It is well recognized that in order for a NCE to achieve reasonable oral absorption, it will need to have adequate aqueous solubility, as well as intestinal permeability [1], Recent advancements in chemistry, such as parallel and combinatorial synthesis, have resulted in a multifold increase in the number of compounds that are available for evaluation in new drug discovery. Furthermore, a variety of improved structural chemistry... 

For any new chemical entity drug, whether or not it has been first marketed abroad, and whether or not it is chemically related to some other approved new drug, FDA requires compliance with the full IND/NDA process. 

Under the centralized procedure, applications are accepted with regard to (a) products of biotechnology (b) new chemical entities (NCEs drugs in which the active ingredient is new). Biotech products are grouped as list A , NCEs as list B . Marketing approval application for biotech products must be considered under the centralized procedure, whereas NCEs can be considered under centralized or decentralized mechanisms. 

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