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Merck Wins Another Federal FOSAMAX® (alendronate Sodium) Bellwether Trial

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2009 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov).

The Prescribing information and Patient Product Information for FOSAMAX ® is attached and is available at:

www.merck.com/product/usa/pi_circulars/f/fosamax/fosamax_pi.pdf www.merck.com/product/usa/pi_circulars/f/fosamax/fosamax_onceweekly_ppi.pdf www.merck.com/product/usa/pi_circulars/f/fosamax/fosamax_oncedaily_ppi.pdf .

FOSAMAX ® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.

9635610

9636810

FOSAMAX ®

(ALENDRONATE SODIUM) TABLETS AND ORAL SOLUTION

 

DESCRIPTION

 

FOSAMAX * (alendronate sodium) is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.

Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate.

The empirical formula of alendronate sodium is C 4H 12NNaO 7P 2•3H 2O and its formula weight is 325.12. The structural formula is:

(Graphic Omitted)

Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform.

Tablets FOSAMAX for oral administration contain 6.53, 13.05, 45.68, 52.21 or 91.37 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5, 10, 35, 40 and 70 mg, respectively, of free acid, and the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, and magnesium stearate. Tablets FOSAMAX 10 mg also contain carnauba wax.

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