FDA Approved Drugs During 2008


The FDA's drug approval process is one that has critics on both sides. The drugmakers often complain that the agency is too slow and too cautious. Critics of the drugmakers often feel that the companies just aren't pumping much out of their research pipelines.

The FDA is charged with overseeing that drugmakers follow "Critical Path" of medical product development. This "Critical Path" is a scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or "proof of concept" into a medical product. It consists of scientific tests and tools used to predict whether a product candidate will be safe and effective, to assess how prototypes interact with the human body, and to guide the sponsor in choosing an appropriate dose and regimen or device size and/or placement. It consists of scientific tools to manufacture the product at commercial scale and assess the quality of the manufactured product. In order to bring a product to market successfully and efficiently, product sponsors need scientifically sound approaches to these challenges.

The FDA seems to be busy as the year ends. Not all drugs are being approved. Recently, the agency declined to approve ustekinumab, a J&J psoriasis drug , and ask for more info on the company's plan for informing physicians and patients about potential risks. The FDA placed 46 new or updated black-box warning labels in the first three quarters, down from 62 in the same period last year.

"In my sixteen and a half years at FDA, I have never received or issued an order to speed up or slow down," said John Jenkins, director of FDA's Office of New Drugs. "We review each application on its merits and apply our best judgment with regard to the data, science and regulations."

The drugmakers complain that there have been missed review dates. Recent examples of missed review goals include Amgen's novel blood-thickening drug Nplate, approved a month after its target date. Meanwhile, Astellas Pharmaceutical's heart rhythm drug vernakalant received a request for more safety data in August, more than half a year after its target date. The company is still waiting for a decision.

Following is a list of Drugs Approved During 2008

1. Accretropin (somatropin rDNA Original); For the treatment of growth failure in pediatrics; Cangene Corp; Approved January 2008

2. Alvesco (ciclesonide); For the maintenance treatment of asthma as prophylactic therapy in adults and adolescents; Nycomed; Approved January 2008

3. Intelence (etravirine); For the treatment of HIV-1; Tibotec; Approved January 2008

4. Moxatag (amoxicillin); For the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatrics; MiddleBrooke Pharmaceuticals; Approved January 2008

5. Tysabri (natalizumab); For the maintenance treatment of moderate to severe Crohn's disease; Biogen IDEC; Approved January 2008

6. Welchol (colesevelam hydrochloride); For the improvement of glycemic control in adults with type 2 diabetes mellitus; Daiichi Sankyo; Approved January 2008

7. Aplenzin (bupropion hydrobromide); For the treatment of major depressive disorder; Biovail Labs; Approved April 2008

8. Cimzia (Certolizumab Pegol); For the treatment of Crohn's disease; UCB Inc.; Approved April 2008

9. Orencia (abatacept); For the treatment of Juvenile Idiopathic Arthritis; Bristol-Myers Squibb; Approved April 2008

10. Patanase (olopatadine hydrochloride); For the treatment of seasonal allergic rhinitis; Alcon; Approved April 2008

11. Rotarix (Rotavirus Vaccine, Live, Oral); For the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in pediatrics; GlaxoSmithKline; Approved April 2008


12. Entereg (alvimopan); For the treatment of postoperative ileus; GlaxoSmithKline; Approved May 2008

13. Aptivus (tipranavir); For the treatment of HIV; Boehringer Ingelheim; Approved June 2008

14. Durezol (difluprednate); For the treatment of inflammation and pain associated with ocular surgery; Sirion Therapeutics; Approved June 2008

15. Stavzor (valproic acid delayed release); For the treatment of bipolar manic disorder, seizures and migraine headaches; Banner Pharmacaps; Approved July 2008

16. Cleviprex (clevidipine); For the treatment of hypertension when oral therapy is not feasible or not desirable; The Medicines Company; Approved August 2008

17. Nplate (romiplostim); For the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura; Amgen; Approved August 2008

18. Viread (tenofovir disoproxil fumarate); For the treatment of hepatitis B; Gilead; Approved August 2008

19. Xenazine (tetrabenazine); For the treatment of chorea due to Huntington's disease; Prestwick Pharma; Approved August 2008

20. Sancuso (granisetron); For the treatment of chemotherapy-induced nausea and vomiting; ProStrakan; Approved September 2008

21. Akten (lidocaine hydrochloride); For anesthesia during ophthalmologic procedures; Akorn; Approved October 2008

22. Cinryze (C1 Inhibitor (Human)); For the treatment of angioedema attacks in adolescents/adults with Hereditary Angioedema; Lev Pharmaceuticals; Approved October 2008

24 Toviaz (fesoterodine fumarate); For the treatment of overactive bladder; Pfizer; Approved October 2008

25. Treanda (bendamustine hydrochloride); For the treatment of Chronic lymphocytic leukemia and B-cell non-Hodgkin's lymphoma; Cephalon; Approved October 2008

26. Vimpat (lacosamide); For the treatment of partial-onset seizures in adults with epilepsy; Schwarz Pharma; Approved October 2008

27. Banzel (rufinamide); For the treatment of seizures associated with Lennox-Gastaut syndrome in pediatrics and adults; Eisai; Approved November 2008

28. Gleevec (imatinib mesylate) for a new indication – keeping cancer from growing in patients following surgical removal of a gastrointestinal stromal tumor or GIST. Approved December 2008

29. Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer. Approved December 2008


FDA approves more drugs, still misses deadlines (AP Press)
FDA approvals up in '08, missed deadlines abound (FierceBioTech)
Center Watch -- 2008 Approved Druglist
FDA Website