A 505(b)(2) is provision to seek the regulatory approval without conducting the studies or taking right of reference for new products. There are three regulatory pathways to get the marketing approval for new products in federal register of drug products; 505 (b)(1)New drug application, 505 (b)(2) Hybrid NDA and 505 (j) for ANDA. 505(b)(2) provision has made to avoid the duplication of study, reduce the development time and cost. Topical drug development is popular now days and most of the companies are diverted to topical formulation development. The topical drug development for 505 (b)(2) is useful for long term business, get exclusive marketing rights and get easy entry into market with branded product. A 505(b)(2) involves the no or minimum nonclinical and clinical studies to prove safety and effectiveness of the new products. The choice of RLD Selection and excipients selection also minimizes the number studies required. In last 5 years on an average USFDA has approved 505(b)(2) products and majority are new dosage forms. Typical examples from different filing strategy are discussed related to Topical and transdermal products.
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