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Status:
US Approved Rx
(2005)
Source:
NDA021332
(2005)
Source URL:
First approved in 2005
Source:
NDA021332
Source URL:
Class:
PROTEIN
Conditions:
Pramlintide is an analog of human amylin. Amylin is co-secreted with insulin from pancreatic beta cells and acts centrally to slow gastric emptying, suppress postprandial glucagon secretion, and decrease food intake. These actions complement those of insulin to regulate blood glucose concentrations. Amylin is relatively deficient in patients with type 2 diabetes, depending on the severity of beta-cell secretory failure, and is essentially absent in patients with type 1 diabetes. Through mechanisms similar to those of amylin, pramlintide improves overall glycemic control, reduces postprandial glucose levels, and reduces bodyweight in patients with diabetes using mealtime insulin. SYMLIN® (pramlintide acetate) is indicated for patients with type 1 or type 2 diabetes who use mealtime insulin and have failed to achieve desired glycemic control despite optimal insulin therapy.
Status:
US Approved Rx
(2005)
Source:
BLA021878
(2005)
Source URL:
First approved in 2005
Source:
BLA021878
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Insulin detemir, a long-acting human insulin analog, is sold under the brand name LEVEMIR to improve glycemic control in adults and children with diabetes mellitus. Insulin detemir binds to the insulin receptor. Receptor-bound insulin lowers blood glucose by facilitating cellular uptake of glucose into skeletal muscle and adipose tissue and by inhibiting the output of glucose from the liver. The primary activity of insulin detemir is the regulation of glucose metabolism. Insulin detemir crosses the BBB and reduces food intake, it improves weight management by an enhanced and prolonged centrally mediated reduction of energy intake.
Status:
US Approved Rx
(2005)
Source:
BLA125118
(2005)
Source URL:
First approved in 2005
Source:
BLA125118
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2019)
Source:
BLA761099
(2019)
Source URL:
First approved in 2004
Source:
BLA125085
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2004)
Source:
NDA021256
(2004)
Source URL:
First approved in 2004
Source:
NDA021256
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Human secretin is a gastrointestinal peptide hormone that regulates secretions in the stomach, pancreas, and liver. Synthetic human secretin displays equivalent biological activity and properties as naturally occurring secretin. Acetate salt of synthetic secretin was marketed under the name ChiRhoStim. ChiRhoStim is indicated for the stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction, for the gastrin secretion to aid in the diagnosis of gastrinoma. ChiRhoStim is also used for the pancreatic secretions to facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic, retrograde cholangiopancreatography (ERCP). When secretin binds to secretin receptors on pancreatic duct cells it opens cystic fibrosis transmembrane conductance regulator (CFTR) channels, leading to secretion of bicarbonate-rich-pancreatic fluid.
Status:
US Approved Rx
(2004)
Source:
BLA021629
(2004)
Source URL:
First approved in 2004
Source:
BLA021629
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2004)
Source:
BLA125104
(2004)
Source URL:
First approved in 2004
Source:
BLA125104
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2004)
Source:
BLA125103
(2004)
Source URL:
First approved in 2004
Source:
BLA125103
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2004)
Source:
NDA021060
(2004)
Source URL:
First approved in 2004
Source:
NDA021060
Source URL:
Class:
PROTEIN
Conditions:
Ziconotide (PRIALT; SNX-111) is a neuroactive peptide, which was approved by FDA in 2004 for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine. Ziconotide acts as a selective N-type voltage-gated calcium channel blocker, which leads to a blockade of excitatory neurotransmitter release from the primary afferent nerve terminals.
Status:
US Approved Rx
(2004)
Source:
BLA125084
(2004)
Source URL:
First approved in 2004
Source:
BLA125084
Source URL:
Class:
PROTEIN