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

Generic Drug Approvals by FDA - November 2009

A quick view on the Generic drug approvals by US FDA this month (Nov'09).

1. Akorn Inc and Alcon Inc has obtained two generic drug approvals this year for KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION (0.4%, 0.5%); Notably, Apotex Inc and Sun Pharma has obtained one approval each (0.4%, 0.5% respectively) for the same drug.

2. One of the generic drug competitor, Barr Laboratories have got an approval on NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS (1 MG/0.005 MG)

3. Another generic drug competitor, Teva Pharmaceuticals and Matrix laboratories have obtained approval for LANSOPRAZOLE DELAYED-RELEASE CAPSULES (15 MG and 30 MG)

4. The Indian pharma company, Aurobindo Pharma and Roxane laboratories, Ivax Pharmaceuticals (a subsidiary of Teva) have got nod for PERINDOPRIL ERBUMINE TABLETS (2 MG, 4 MG and 8 MG)

5. Par pharmaceuticals got approval for TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS (100 MG and 200 MG)    

6. The drug, NICARDIPINE HYDROCHLORIDE INJECTION (2.5 MG/ML; PACKAGED IN 25 MG/10 ML) was approved for Generamedix Inc, Pharmaforce Inc, Vavinta LLC, Sun pharma and Wockhardt Ltd.

7. NIZATIDINE ORAL SOLUTION (15 MG/ML) was approved to Amneal Pharmaceuticals.

NDA approvals (01-Jan-2008 to 30-Nov-2008)

FDA has approved about 83 New Drugs in 36 different therapeutic areas for the period of 01-Jan-2008 to 11-Nov-2008. Maximum of eight new Anti-retrovirals are approved, followed by six anti-histamine, anti-convulsant and anti-inflammatory each approved by US FDA.

Other New Drugs approved by FDA (Jan'08 to Nov'08)

Other therapeutics approved by ANDA

FDA- ANDA approved Therapeutics

ANDA approvals from Jan'08 to Nov08

ANDA approvals from US FDA [01-Nov'08 to 30-Nov'08]