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Orphan drugs approved

Refer to Section 8.2.4. The orphan drug approval mechanism is implemented to provide incentives to pharmaceutical companies to research and develop drugs for diseases with small patient groups where otherwise commercial returns are considered to be lower than other diseases with large patient pools. [Pg.275]

Oral 10 mg/mL solution. Note Orphan drug approved only for the treatment of narcotic addiction. Levorphanol (generic, Levo-Dromoran)... [Pg.706]

The number of orphan drugs approved in 1997 were 9 ingredients or 9 prod-... [Pg.276]

Source FDA website, www.fda.gov/orphan/designat/list.htm. Note that approvals originally granted to companies later merged with the current top 10 pharma companies, such as orphan drug approvals to Pharmacia Upjohn, now part of Pfizer, were not counted in this percentage. [Pg.52]

With over 650 active designations and now about 275 orphan drugs approved for the market (and even one medical device), plus numerous grants awarded since 1983, the Act has clearly been a success. Let us not forget that nothing in the Act creates compulsion, and that voluntary participation, as measured by applications for designation submitted, increase year by year. [Pg.209]

All new drug applications are expected to be in the CTD format according to ICH guidelines (see Section 7.11). Priority reviews are applicable for orphan drugs and those drugs for the treatment of serious illnesses. A restricted approval system has been implemented for emergency drugs to prevent spread of diseases. In this case, the standard review procedure is not applicable. [Pg.217]

Explain the meaning of an orphan drug. Why is it necessary to have a separate approval route for orphan drugs ... [Pg.274]

In September 2007, the EMEA approved the use of trabectidin against ovarian cancer (OC) and STS. In November 2009, Yondelis received its second marketing authorization from the European Commission for its administration in combination with pegylated liposomal doxorubicin (Doxil, Caelyx) for the treatment of women with relapsed ovarian cancer presently, trabectedin (36) is under Phase II trials for the treatment of paediatric sarcomas as well as breast and prostate cancers. The European Commission and the US Food and Drug Administration (FDA) have granted orphan drug status to trabectedin for soft tissue sarcomas and... [Pg.42]

An orphan drug is one that is intended for use in rare diseases and thus for which there is not a sufficient market to justify the investment needed to demonstrate safety and effectiveness in order to obtain approval of an NDA. Por more than 20 years PDA had permitted orphan drugs to be distributed through a permanent IND, with little or no thought that it would ever progress to an approved NDA. In 1983, Congress enacted the Orphan Drug Act to provide... [Pg.570]

Figure 7.5. Number of orphan drug marketing approvals, 1980-2000. Figure 7.5. Number of orphan drug marketing approvals, 1980-2000.
TABLE 3.3. Comparisons of indications, approval dates, and revenues of two colony-stimulating factors approved by FDA under the Orphan Drug Classification... [Pg.27]


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See also in sourсe #XX -- [ Pg.632 ]




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