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News »May 2006

CHMP has positive opinion on marketing Acomplia and Zimulti

May 02, 2006

CHMP (The Committee for Medicinal Products for Human Use) has good opinions on initial marketing authorization applications for acomplia and zimulti, the most awaited drugs. The Committee for Medicinal Products for Human Use has 32 members and a chairman. Each member is nominated by EMEA (European Agency for the Evaluation of Medical Products), the responsible authority for protection and promotion of animal and human health.

Acomplia is an anti obesity drug used for the both the treatment for obesity and to get rid of smoking. This drug is also helpful for obese or overweight patients who suffer from type 2 diabetes or dyslipidaemia. EMEA (European Agency for the Evaluation of Medical Products) start reviewing acomplia on 18 May 2005 and continue reviewing till 202 days; for zimulti the reviewing time was 85 days. EMEA start reviewing zimulti on 15 September 2005. Initially before marketing any drug in Europe EMEA review the drug for a certain number of days for the examination of that drug. Look at the reviewing time for some other drugs also which are also being under consideration-

Baraclude (entecavir) from Bristol-Myers Squibb Pharma- 210 days, RotaTeq (rotavirus vaccine) from Sanofi Pasteur- 190 days, Tysabri (natalizumab) from Elan Pharma International Ltd- 176 days, Sutent (sunitinib malate) from Pfizer Ltd- 177 days, Avaglim (rosiglitazone/glimepiride) from SmithKline Beecham plc - 204 days, Nexavar (sorafenib tosylate) from Bayer Healthcare- 177 days. After reviewing a drug for certain duration of time period EMEA allows for marketing that drug in Europe.

Read the complete news story here:
http://www.medicalnewstoday.com/medicalnews.php?newsid=42542

 



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