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FDA February 2013 Products Receiving Orphan Designation

March 1, 2013

The chart below identifies the FDA February 2013 Products Receiving Orphan Designation. The chart is generated from the FDA’s Orphan Drug Product Designation Database Application and is current as of March 1, 2013. The chart is created by performing a search for the following date range :

Start Date: 02/01/2013 & End Date: 02/28/2013.

Generic Name

Designation   Date

Indication

1) 2-hydroxypropyl-B-cyclodextrin 02-18-2013 Niemann-Pick   Disease Type C
2) Allogeneic   ex-vivo expanded placental adherent stromal cells 02-18-2013 Aplastic   Anemia
3) Human   insulin beta chain peptide with incomplete Freund’s adjuvant vaccine 02-11-2013 Type 1   Diabetes With Residual Beta Cell function
4) Idursulfase   beta 02-11-2013 Hunter   Syndrome (Mucopolysaccharidoses)
5) Testosterone   undecanoate (oral) 02-13-2013 Constitutional   Delay in Growth Puberty in Adolescent Boys (14-17 yrs of age)
6) Minnelide 02-18-2013 Pancreatic   Cancer

** “Generic Name” Column Link = Is the FDA Orphan Drug Product Designation Database Record.

Please Note: FDA Official Logo from FDA website.

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