CENTER FQR DRUQ EVALIJA ! IQN AND RESEARng
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`Appligatign [Sumhen NDA 20845
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`APPRQVAL LETTER 4
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`:‘ ¢ DEPARTMENT OF HEALTH & HUMAN SERVICES
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`NDA 20-845
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`DEC 2 3 LET-5:;
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`Food and Drug Adminimetion
`Roekviile MD 20857 .
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`[N0 Therapeutics. Inc.
`Attention: Richard N. Williams. PhD.
`54 Old Highway 22
`Clinton, NJ 08809
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`‘
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`Dear Dr. Williams:
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`Please refer to your new dmg application (NBA) dated June 16. 1997. withdrawn on
`September E7. «1997 and resubmitted on May 26. 1999. under section 505(b) of the Federal Food.
`Drug. and Cosmetic Act for INOmax (nitric oxide) I00 and 800 ppm for Inhalation.
`wé acknowledge receipt of your submissions dated December 8. 1999 (two).
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`Validatitm of the regulatory methods has not been completed. At the present time. it is the policy
`of the Center not to withhold approval because the methods are being validated. Nevertheless. we
`expect your continued cooperation to resolve any problems that may be identified.
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`i
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`‘ We remind you that you must comply with the requirements for an approved NDA set forth under
`2| CFR314.30ahd 314.81.
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`NDA 20—845
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`Page 2
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`If ynu have any questions. please contact:
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`Ms. Zelda McDonald
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`Regulatory Project Manager
`(301) 594-5333
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`..._ 1
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`_ Sinccrclv van"
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`9431/6”
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`oben Temple. MI.)
`Director
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`‘ Office of Drug Evaiuation I
`Center for Drug Evaluation and Research
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`CENTER FOR DRUG EVALUATION AND RESEARCH
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`APPLI ATI
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`MBER' NDA 20845
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`APPR£ 1 Y ABLE LETTER
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`DEPARTMENT or HEALTH a. HUMAN SERVICES
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`Public Health Service
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`Food and Drug Administration
`Rockville MD 20857
`NOV 19
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`NDA 20—845
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`.
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`lNO Therapeutics, Inc.
`' Attention: Richard N. Williams, Ph.D.
`54 Old Highway 22
`Clinton NJ 08809
`
`Dear Dr. Williams:
`
`Please refer to your new drug application (NDA) dated June 16, I997, withdrawn on
`September 17, 1997 and resubmitted on May 26, 1999 under section 505(b) of the Federal Food,
`Drug, and Cosmetic Act for lNOmax (nitric oxide) 100 and 800 ppm for Inhalation.
`
`We note you submitted manufacturing and controls information, dated February 26, 1997. We
`also acknowledge receipt of your submissions dated June 10, 17 and 27, July 11 and 31,
`August 15, 18, 22 (two) and 28 (three), and September 8, 12 (three) and 16 (four), 1997;
`March 30, April 1 and December 15, 1998;1une l and 4, August 13, September 27, and
`November 6, 1999.
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`We have completed the review of this application, as amended, and it is approvable. Before this
`application may be approved, however. it will be necessary for you to submit final printed
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`labeling (FPL) for the drug. The package insert should be identical in content to the enclosed
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`marked-up draft. The immediate container and carton labeling should be identical to the
`submitted draft (immediate container and carton labels submitted November 6, 1999), except that
`the storage statement should be changed to the following:
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`Store at 25° C (77° F) with excursions permitted between lS-30° C (59-86° F) [see USP
`Controlled Room Temperature].
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`This storage statement should be included on all labeling (package insert, and immediate
`container and carton labels).
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`The expiration date for drug product stored at 25° C will be 30 months.
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`Please submit 20 copies of the final printed labeling ten of which are individually mounted on
`heavy weight paper or'sirnilar material.
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`If additional information relating to the safety or effectiveness of this drug becomes available,
`. revision of the labeling may be required.
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`In addition, please submit three copies of the introductory promotional materials that you propose '
`to use for this product. All proposed materials should be submitted in draft or mock-up form, not.
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`N_DA 20-845
`Page 2
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`final print. Please send one copy to the Division of Cardio-Renal Drug Products and two copies
`of both the promotional materials and the package insert directly to:
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`Division of Drug Marketing,'Adveitising. and Communications, I-lFD-4O
`Food and Drug Administration
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`5600 Fishers Lane
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`~ Rockville, Maryland 20857
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`Within 10 days after the date of this letter, you are required to amend the application, notify us of
`your intent to file an amendment, or follow one of your other Options under 21 CFR 314.110. In
`the absence of any such action FDA may proceed to withdraw the application. Any amendment
`should respond to all the deficiencies listed. We will not process a partial reply as a major
`amendment nor will the review clock be reactivated until all deficiencies have been addressed.
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`The drug product may not be legally marketed until you have been notified in writing that the
`application is approved.
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`If you have any questions, please contact:
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`._
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`Zelda McDonald
`Regulatory Health Project Manager
`(301) 594-5333.
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`Sincerely yours,
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`Robert Temple, MD.
`Director
`‘
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`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`Enclosure
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