New Drug Approvals Archive - April 2005

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
• Fosamax Plus D (alendronate and cholecalciferol) FDA Approval History

Retisert (fluocinolone acetonide) Intravitreal Implant

Date of Approval: April 8, 2005
Company: Bausch & Lomb
Treatment for: Uveitis

Retisert (fluocinolone acetonide) intravitreal implant is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

• Retisert Bausch & Lomb - Treatment for Chronic Non-Infectious Uveitis
• Retisert (fluocinolone acetonide) FDA Approval History

Byetta (exenatide) Injection

Date of Approval: April 28, 2005
Company: Amylin Pharmaceuticals / Eli Lilly & Co.
Treatment for: Diabetes Type 2

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
• Byetta (exenatide) FDA Approval History

Byetta (exenatide)

New Indication Approved: November 2, 2009

• Byetta Approved for Expanded Use as First-Line Treatment for Type 2 Diabetes
• Byetta (exenatide) FDA Approval History

Byetta (exenatide)

New Dosage Regimen: October 19, 2011

• Byetta Approved for Use with Insulin Glargine in the U.S.
• Byetta (exenatide) FDA Approval History