New Drug Approvals Archive

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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 (alendronate and cholecalciferol) FDA Approval History

April 8

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 (fluocinolone acetonide) FDA Approval History

April 28

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 (exenatide) FDA Approval History

November 2

Byetta (exenatide)

New Indication Approved: November 2, 2009

Byetta (exenatide) FDA Approval History

October 20

Byetta (exenatide)

New Dosage Regimen: October 19, 2011

Byetta (exenatide) FDA Approval History

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