In the first 7 months of 2011, the FDA has approved 18 new molecular entity pharmaceutical drugs (and no biologic NMEs)

In the first seven months of 2011 (January 14 to July 20) , the US FDA has already approved 18 new molecular entity drugs. These are some notes on the approvals:

  • All of the NME products are considered pharmaceutical drugs, and received approval under FDA procedures for New Drug Applications (NDA).
  • Despite the trends indiciating shifts to biologic products from pharmaceutical drugs, none of the 2011 products introduced to date were biologics.
  • One third (6 of 18) received Priority review status. 12 of 18 received Standard review status.
  • Of the 18 drugs, US based companies owned 9, German and UK companies 3 and one each for Japanese and Swiss firms.
  • Of the companies that received approval this year, Johnson and Johnson developed 3, AstraZeneca 2, Bayer 2 and Forest Labs 2. Ten more companies developed 1 drug each.
  • Uses for these drugs were varied. Two (Zytiga and Vandetanib) are for cancer. Additionally, there are two drugs approved to treat COPD (Arcapta and Daliresp) and hepatitis C (Victrelis and Incivek), and two anticonvulsants (Horizant and Xarelto). There is 1 new HIV treatment (Edurant)

2011 FDA New Molecular Entity Approvals, January – July

INN Brand name Approval Type App no Chemical Type Review status Applicant Date
ioflupane i-123 datscan nda 22454 1 p ge hlthcare inc 01/14/2011
spinosad natroba nda 22408 1 s parapro pharms 01/18/2011
vilazodone hydrochloride viibryd nda 22567 1 s forest labs inc 01/21/2011
azilsartan medoxomil edarbi nda 200796 1 s takeda pharms 02/25/2011
roflumilast daliresp nda 22522 1 s forest res inst inc 02/28/2011
gadobutrol gadavist nda 201277 1 s bayer hlthcare 03/14/2011
vandetanib vandetanib nda 22405 1 p ipr pharms inc 04/06/2011
gabapentin enacarbil horizant nda 22399 1 s glaxo grp ltd 04/06/2011
abiraterone acetate zytiga nda 202379 1 p centocor ortho 04/28/2011
linagliptin tradjenta nda 201280 1 s boehringer ingelheim 05/02/2011
boceprevir victrelis nda 202258 1 p schering 05/13/2011
rilpivirine hydrochloride edurant nda 202022 1 s tibotec 05/20/2011
telaprevir incivek nda 201917 1 p vertex pharms 05/23/2011
fidaxomicin dificid nda 201699 1 p optimer pharms 05/27/2011
ezogabine potiga nda 22345 1 s valeant pharms 06/10/2011
indacaterol maleate arcapta nda 22383 1 s novartis pharms 07/01/2011
rivaroxaban xarelto nda 22406 1 s johnson and johnson 07/01/2011
ticagrelor brilinta nda 22433 1 s astrazeneca lp 07/20/2011
Uncategorized

Paul Miano