NDA and BLA approvals by US FDA – November 2009

1. Only one New molecular entity (NME) has been approved by FDA in this month.
 Drug Name: ISTODAX
 Company: Gloucester Pharms
 Active ingredient: ROMIDEPSIN
 Review Class: Standard review drug

2. Four new formulations has been approved as shown below:
 Drug Name: LYSTEDA
 Company: Xanodyne Pharm
 Active ingredient: TRANEXAMIC ACID
 Review Class: Priority review drug

 Drug Name: NEXCEDE
 Company: Novartis
 Active ingredient: KETOPROFEN
 Review Class: Standard review drug

 Drug Name: REVATIO
 Company: Pfizer
 Active ingredient: SILDENAFIL CITRATE
 Review Class: Standard review drug

 Drug Name: PENNSAID
 Company: Nuvo Res
 Active ingredient: DICLOFENAC SODIUM
 Review Class: Standard review drug

3. One drug which is already in market (with out approval from FDA) for approved.
 Drug Name: QUTENZA
 Company: Neurogesx
 Active ingredient: CAPSAICIN
 Review Class: Standard review drug

4. A drug with out any NDA chemical type classification is also approved by US FDA
 Drug Name: KALBITOR
 Company: Dyax Corp
 Active ingredient: ECALLANTIDE
 Review Class: Unspecified