An application was filed for approval for its weekly diabetes medicine named as Bydureon, a product of Amylin Pharmaceuticals.
Finally FDA has approved the drug. Bydureon is type 2 Diabetes drug to be taken once a week.
Unlike other diabetes drugs such as generic Actos, generic Amaryl and generic Avandia, Bydureon is in injection diabetes medicine. A manufacturing division located at 8814 Trade Port Drive will be producing these injections.
Amylin announced about the approval given on 27th January by FDA. Company has planned to launch the drug in February 2012. Diabetes patients can expect to see the drug in pharmacies in mid February 2012.
Bydureon (exenatide) is receptor agonist for glucagon-like peptide-1 (GLP-1) which improves glycemic control in type 2 diabetes patients. Efficacy of Bydureon is said to be best when administered with proper diet and exercise. Diabetes Medicines
Amylin first launched its manufacturing plant in 2009 and for Bydureon it received, along with other companies such as Lilly and Alkemes, response letter from FDA on April 23 2010. By the time US FDA approves the drug, Amylin launched the drug in Europe Commission which got approval in 2011. Bydureon is also in approval queue in Asian countries like Japan.
Industry experts are happy that finally long acting diabetes drug will be available to millions of diabetes patients in USA. Eyes are on how the drug is going to perform in market.
Amylin is however is not planning to hire more staff because of approval as current staff unit is already manufacturing Bydureon for European market. As USA approval was soon expected, company employees already had increased production.
According to company current numbers of employees are ample to meet demand and it is prepared to hire new people if demand increases.
Finally FDA has approved the drug. Bydureon is type 2 Diabetes drug to be taken once a week.
Unlike other diabetes drugs such as generic Actos, generic Amaryl and generic Avandia, Bydureon is in injection diabetes medicine. A manufacturing division located at 8814 Trade Port Drive will be producing these injections.
Amylin announced about the approval given on 27th January by FDA. Company has planned to launch the drug in February 2012. Diabetes patients can expect to see the drug in pharmacies in mid February 2012.
Bydureon (exenatide) is receptor agonist for glucagon-like peptide-1 (GLP-1) which improves glycemic control in type 2 diabetes patients. Efficacy of Bydureon is said to be best when administered with proper diet and exercise. Diabetes Medicines
Amylin first launched its manufacturing plant in 2009 and for Bydureon it received, along with other companies such as Lilly and Alkemes, response letter from FDA on April 23 2010. By the time US FDA approves the drug, Amylin launched the drug in Europe Commission which got approval in 2011. Bydureon is also in approval queue in Asian countries like Japan.
Industry experts are happy that finally long acting diabetes drug will be available to millions of diabetes patients in USA. Eyes are on how the drug is going to perform in market.
Amylin is however is not planning to hire more staff because of approval as current staff unit is already manufacturing Bydureon for European market. As USA approval was soon expected, company employees already had increased production.
According to company current numbers of employees are ample to meet demand and it is prepared to hire new people if demand increases.
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