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`DEPARTMENT OF HEALTH 8t HUMAN SERVICES
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`Food and Drug Administration
`Rockville MD 20857
`
`NDA 20-845
`
`DEC 2 3 but;
`
`INO Therapeutics. Inc.
`Attention: Richard N. Williams, PhD.
`54 Old Highway 22
`Clinton, NJ 08809
`
`Dear Dr. Williams:
`
`Please refer to your new drug application (NDA) dated June 16, 1997. withdrawn on
`September I7. 1997 and resubmitted on May 26. 1999, under section 505(b) of the Federal Food.
`Drug, and Cosmetic Act for INOmax (nitric oxide) 100 and 800 ppm for Inhalation.
`
`We acknowledge receipt of your submissions dated December 8. 1999 (two).
`
`This new drug application provides for the use of lNOmax (nitric oxide) 100 and 800 ppm for
`Inhalation . in conjunction with ventilatory support and other appropriate agents, in the treatment
`of term and near-term (> 34 weeks) neonates with hypoxic respiratory failure associated with
`clinical or echOeardiographic evidence of pulmonary hypertension. where it improves
`oxygenation and reduces the need for extracorporeal membrane oxygenation.
`
`We have cempleted the review of this application. as amended, and have concluded that adequate
`information has been presented to demonstrate that the drug product is safe and effective for use
`as recommended in the submitted final printed labeling (package insert submitted, immediate
`container and carton labels included in your December 8, 1999 submission). Acc0rdingly, the
`application is approved effective on the date of this letter.
`
`Validation 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.
`
`Be advised that, as of April 1, 1999, all applications for new active ingredients, new dosage
`forms, new indications. new routes of administratioa, and new dosing regimens are required to
`contain an assessment of the safety and effectiveness of the product in pediatric patients unless
`this requirement is waived or deferred (63 FR 66632). We note that you have fulfilled the
`pediatric study requirement at this time.
`
`We remind you that you must comply with the requirements for an approved NDA set forth under
`2] CFR 314.80 and 314.8}.
`
`

`

`NDA 20-845
`
`Page 2
`
`If you have any questions. please contact:
`
`Ms. Zelda McDonald
`
`Regulatory Project Manager
`(301) 594-5333
`
`Sincerelv Vmu-c
`
`*431/-
`
`/,
`
`Robert Temple, MD —‘
`Director
`
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`