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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 19-558/S-053 + 15 others
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Merck Sharp & Dohme Corp.
`Attention: Jeffrey Tucker, M.D.
`Senior Director, Regulatory Affairs
`P.O. Box 1000, UG2CD-48
`North Wales, PA 19454-1099
`
`
`Dear Dr. Tucker:
`
`Please refer to your Supplemental New Drug Applications (sNDAs) dated and received March
`12, 2010, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA)
`for the following:
`
`NDA
`19-558
`20-386
`20-685
`20-387
`
`22-145
`22-044
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`21-995
`19-643
`19-384
`19-778
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`Supplement
`S-053
`S-053
`S-072
`S-050
`
`S-015
`S-015
`
`S-016
`S-082
`S-055
`S-044
`
`
`
`Product
`Prinivil® (lisinopril) Tablets, 5 mg, 10 mg, 20 mg
`Cozaar® (losartan potassium) Tablets, 25 mg, 50 mg, 100 mg
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`Crixivan® (indinavir sulfate) Capsules, 100 mg, 200 mg, 400 mg
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`Hyzaar® (losartan potassium-hydrochlorothiazide) Tablets,
`50-12.5 mg, 100-12.5 mg, 100-25 mg
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`Isentress® (raltegravir) Tablets, 400 mg
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`Janumet® (sitagliptin/metformin HCl) Tablets, 50/500 mg
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`50/1,000 mg
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`Januvia™ (sitagliptin) Tablets, 25 mg, 50 mg, 100 mg
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`Mevacor® (lovastatin) Tablets, 20 mg, 40 mg
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`Noroxin® (norfloxacin) Tablets, 400 mg
`Prinzide® (lisinopril-hydrochlorothiazide) Tablets, 10-12.5 mg
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`20-12.5 mg
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`Propecia® (finasteride) Tablets, 1 mg
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`Proscar® (finasteride) Tablets, 5 mg
`Singulair® (montelukast sodium) Tablets, 10 mg
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`Singulair® (montelukast sodium) Chewable Tablets, 4 mg, 5 mg
`Zocor® (simvastatin) Tablets, 5 mg, 10 mg, 20 mg, 40 mg, 80 mg
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`Zolinza® (vorinostat) Capsules, 100 mg
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`S-016
`S-035
`S-054
`S-055
`S-079
`S-005
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`20-788
`20-180
`20-829
`20-830
`19-766
`21-991
`
`We acknowledge receipt of your amendments dated December 16, 2010, and March 2, 2011.
`
`The December 16, 2010, submissions constituted a complete response to our September 10,
`2010, action letter.
`
`
`Reference ID: 2959184
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`

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` NDA 19-558/S-053 + 15 others
`Page 2
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`These “Prior Approval” supplemental new drug applications provide for a standardized format
`for immediate container labels for the above referenced solid oral drug products.
`
`We have completed our review of these supplemental applications, as amended. They are
`approved, effective on the date of this letter.
`
`We acknowledge your amendment dated March 2, 2011, in which you indicated that you will
`cease the sampling of the Singulair brand by the end of 2011. Therefore, we agree with your
`proposal to deplete the currently approved inventory of physician sample carton labeling.
`
`We remind you of your commitment made in the December 16, 2010, submission that following
`implementation of the new optimized packaging design, Merck will monitor the new design for
`three (3) years, will review any reports of medication errors related to the new design that are
`observed, and report them to the Agency on a quarterly basis.
`
`
`Submit final printed immediate container labels, to each of their respective NDA, that are
`identical to the labels submitted on December 16, 2010, as soon as they are available, but no
`more than 30 days after they are printed.
`
`Please submit these labels electronically according to the guidance for industry titled “Providing
`Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications
`and Related Submissions Using the eCTD Specifications (June 2008).” For administrative
`purposes, designate the submission “Product Correspondence – Final Printed Carton and
`Container Labels for approved NDA ##-###/S-###” (use the appropriate NDA and
`supplement number listed in the table above). Approval of these submissions by FDA is not
`required before the labeling is used.
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`If you have any questions, call Michael Folkendt, Associate Director for Regulatory Affairs, at
`(301) 796-1670.
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`Sincerely,
`
` {See appended electronic signature page}
`
`Moheb M. Nasr
`
` Director
`Office of New Drug Quality Assessment
`Office of Pharmaceutical Science
`Center for Drug Evaluation and Research
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`Reference ID: 2959184
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`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`MOHEB M NASR
`06/10/2011
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`Reference ID: 2959184
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`