New Drug Approvals Archive

New Drug Approvals: April 2005

April 7
Fosamax Plus D (alendronate and cholecalciferol) Tablets

Date of Approval: April 7, 2005

Company: Merck & Co., Inc.

Treatment for: Osteoporosis

Fosamax Plus D is a single once-weekly tablet containing the bisphosphonate drug alendronate, and seven days’ worth of vitamin D, an essential nutrient required for calcium absorption. Fosamax Plus D is used to reduce the risk of hip and spinal fractures in postmenopausal women with osteoporosis, and to increase bone mass in men with osteoporosis.

Fosamax Plus D Merck & Co., Inc. - Treatment for Osteoporosis
 
April 28
Byetta (exenatide) Injection

Date of Approval: April 28, 2005

Company: Amylin Pharmaceuticals / Eli Lilly & Co.

Treatment for: Diabetes Mellitus Type II

Byetta (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Byetta Amylin Pharmaceuticals / Eli Lilly & Co. - Treatment for Type 2 Diabetes
 
November 2
Byetta (exenatide)

New Indication Approved: November 2, 2009

Byetta Approved for Expanded Use as First-Line Treatment for Type 2 Diabetes
 

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