Pipeline

Our core business strategy for our pharmaceuticals business is to exploit our unique drug delivery technology to develop and obtain FDA approval for the marketing and sale of branded generic pharmaceutical products. We intend to seek regulatory approval for our drug candidates by filing “505(b)(2)” applications, an appealing regulatory pathway alternative that permits companies to obtain FDA approval of new drug applications (NDAs) by relying, in part, on the agency’s findings for a previously approved drug. Created in 1984 as part of the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act, the 505(b) (2) application is intended to encourage sponsors to develop innovative medicines using currently available products. According to Section 505(b) (2) guidelines, an NDA approval can be obtained for a new drug without conducting the full complement of safety and efficacy trials and without a “right of reference” from the original applicant. In addition, we may seek regulatory approval for certain drug candidates by filing an abbreviated NDA (ANDA), which is filed for a proposed drug that is identical to a reference listed drug and demonstrates its bioequivalence. For intravenous injection products, Sugar-Lipid Propofol does not change the drug profile; therefore no clinical trial is required for the regulatory approvals.

Product Candidate Portfolio