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`
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`
`DRE ARH
`
`AEELIQATIQE NUMBER: NDA 20845
`
`W
`
`
`
`

`

`
`
`
`NDA 20-345
`
`-
`
`INO Therapeutics. Inc.
`Attention: Richard N. Williams. PhD.
`54 Old Highway 22
`Clinton. N] 08809
`
`Dear Dr. Williams:
`
`1"
`
`7- Ma Dorm-1°”
`
`Food and Drug Administration
`Rockville MD 20857
`
`MAY 28 $99
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`We have received your new drug application (NDA) resubmitted under section 505(b) of the Federal Food. Drug,
`Cosmetic Act for the following:
`
`and
`
`Name of Drug Product: lNOmax (nitric oxide)
`
`Therapeutic Clgssification: Priority (P)
`
`Date of Resubmission: May 24. 1999
`
`.1
`
`Date of Receipt; May 26. 1999
`
`Our Reference Number: 20-845
`
`Unless we notify you within 60 days of our receipt date that
`substantive review. this application will be filed under section 505(b) of the Act on July 25
`21CFR 314.]0](a).
`
`US. Postal Service:
`
`Courier/Overnight Mail:
`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Cardio-Renal Drug Products. HFD-l 10
`Attention: Division Document Room
`5600 Fishers Lane
`'-
`
`Rockville, Maryland 20857
`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Candie—Renal Drug Products. HFD-l 10
`Attention: Division Document Room
`145] Rockville Pike
`
`Rockville. Maryland 20852-1420
`
`
`
`

`

`NDA 20-845
`
`Page 2
`
`If you'havc any questions. please contact:
`
`Ms. Zelda McDonald
`Regulatory Health Project Manager
`(301)594-5333
`
`Sincerely yOurs.
`
`';
`
`"B
`
`Natalia A. Morgenstern
`Chief, Project Management Staff
`Division of Cardio-Renal Drug Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`3
`cc:
`Archival NDA‘20-345
`HFD-l 101m. Files
`
`__
`
`:_
`
`CE
`DISTRJ
`FD-I IOFZMcDonald
`AS 3
`
`filenarne: 20845ac.doc
`
`ACKNOWLEDGEMENT (Ac)
`
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`
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`
`
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`

`
`
`NDA 20-845
`
`Ohmeda Pharmaceutical Products Division Inc.
`Attention: Ms. Priya Jambhekar
`PO. Box 804
`110 Allen Road
`
`Liberty Corner. NJ
`
`07938-0804
`
`Dear Ms. Jambhekar;
`
`Piease refer to your new drug application (NDA) for nitric oxide for inhalation, 400 ppm.
`
`‘
`
`In reviewing your sub'mission of June 16, 1997, our Medical Officer has raised a number of
`questions that require your attention. Our concerns with your submission are detailed as part
`of this correspondence (see enclosure).
`'
`
`Sincerely yours.
`
`Natalia A. Morgenstern
`Chiet;:Project Management Staff
`Division of Cardio-Ftenal Drug Products
`Office of Drug Evaluation |
`Center for Drug Evaluation and Research
`
`Enclosure
`
`Dr. Throckmorton‘s 11/24/97 review. pgs 138-248
`
`cc:
`
`Original NDA
`-_
`0
`
`HFD-110lZMcDonaldl12l4/97
`
`GENERAL WERESPONDENCE
`
`
`
`

`

`
`
`NDA 20-845
`
`Ohmeda Pharmaceutical Products Division Inc.-
`Attention: Ms. Priya Jambhekar
`PO. Box 804
`110 Allen Road
`
`Liberty Corner. NJ
`
`07938-0804
`
`Dear Ms. Jambhekar:
`
`Please refer to your new drug application (NDA) tor nitric oxide.
`
`Sincerely yours;
`
`Natalia A. Morgenstern
`Chief;:-Project Management Staff
`Division of Cardio-Henal Drug Products
`Office of Drug Evaluation l
`Center tor Drug EValuation and Research
`
`.
`
`-.
`_
`
`Enclosure
`
`Dr. Oza's review dated October 10, '1997
`
`CC:
`
`-
`
`Original NDA
`
`HFD.—.J_10-
`(
`/i-TEo-110/2Mco_gnaIu/10/21/e7
`sbllO/27197
`
`GENERAL OORRESPONDBKJE
`
`
`
`

`

`
`
`’
`—— .
`/@ DEPARTMENT or HEALTH aHUMAN SERVICES
`
`qu ’20-845
`
`dhmeda Pharmaceutical Products Division Inc.
`Attention: Ms. Priya Jambhekar
`P.O. Box 804
`110 Allen Road
`Liberty Corner, NJ
`
`07938-0804
`
`Dear Ms. Jambhekan
`
`' -
`
`2. Marmara
`Public Health Service
`
`Food and Drug Administration
`Rockville MD 20357
`
`55p 29 l997
`
`We acknowledge the receipt of your September 16. 1997 communication requesting withdrawal
`of your pending new drug application (NDA) for lNOmax (nitric Oxide) for inhalation.
`in compliance with your request and as provided under 21 CFR 314.65, the application is
`withdrawn as of the date of our receipt of your request for withdrawal, September 17, 1997.
`This withdrawal does not prejudice any future resubmission. You may request that the
`information contained in the withdrawn application be considered in conjunction with any
`resubmission.
`
`-.
`
`1
`
`-
`
`Under section 736(a)(1)(A)(iij(ll) of the Prescription Drug User Fee Act of 1992 (PDUFA),
`the remaining 50% of the user fee is due upon withdrawal after filing of a pending application.
`if you decide to resubmit your application at a future time. under section 736(a)(1)(C) of the
`PDUFA, the submissionwill not be subject to a fee?
`
`If you have any questions, please contact:
`
`Ms. Zelda McDonald
`Regulatory Health Project Manager
`(301)
`594-5333
`
`Sincerely yours.
`
`Natalia A. Morgenstern
`Chief. Project Management Staff
`Division of Cardin-Renal Drug Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`
`
`

`

`
`
`NDA 20-845
`
`Ohmeda Pharmaceutical Products Division Inc.-
`Attention: Ms. Priya-Jambhekar
`P.O. Box 804
`
`110 Allen Road
`
`.
`
`Liberty Corner, NJ
`
`07938-0804
`
`Dear Ms. Jarnbhekar:
`
`.
`
`Please refer to your new drug application (NDA) for nitric oxide for inhalation, 400 ppm.
`
`in reviewing your suthission of June 16, 1997, our Medical Officer has raised a number of
`questions that require your attention. Our concerns with your submission are detailed as part
`of this correspondence (see enclosure).
`
`-
`
`I
`
`Sincerely yours.
`
`Natalia A. Morgenstern
`ChiefgiProject Management Staff
`Division of Cardio~Renal Drug Products
`Office of Drug Evaluation l
`Center for Drug Evaluation and Research
`
`Enclosure
`
`L. Miriam Pina. M.D.'s 8/25/97 review
`
`CC:
`
`Original NDA
`'
`,
`HFD-
`FD-110/ZMcDonald/9f9/97
`sb/
`\— .
`
`GENERAL CORRESPONDENCE
`
`_
`
`
`
`

`

`50
`
`V
`
`5' -/¢ DEPARTMENT or HEALTH e. HUMAN SERVICES
`
`:1.
`
`RDA 20-345
`
`Ohmeda Pharmaceutical Products Division Inc.
`Attention: Ms. Priya Jambhekar
`'
`P.0. Box 804
`110 Allen Road
`Liberty Corner, NJ
`
`07938-0804
`
`Dear Ms. Jambhekar:
`
`"
`
`Z— wamdw
`
`Pub“c Health Service
`
`Food and Drug Administration'
`Rockville MD 20857
`
`JUN 19 1997
`
`We have received your new drug application (NDA) submitted under section 505(b) of the
`Federal Food, Drug. and Cosmetic Act for the following:
`-
`Name oi Drug Product:
`l-NO (nitric oxide)
`
`Therapeutic Classification: P
`
`Date of Application: June 16. 1997
`
`.2
`
`Date of Receipt: June 16. 1997
`
`Our Reference Number: NDA 20-845
`
`ief report on the status of the review
`'
`ultimate approvability. Please request the meeting at least 15 da '
`you may choose to receive such a report by telephone. Should you wish a conference. a telephone
`report, or if_ you have any questions concerning this NDA. please 0ontact:
`
`Ms. Zelda McDonald
`Regulatory Health Project Manager
`(301)
`594-5333
`
`l
`
`
`
`
`
`

`

`Page 2 - NDA 20-845
`
`Please cite the NDA number listed above at the top of the first page of any' communications
`concerning this application.
`
`Sincerely yours,
`
`a
`
`Natalia A. Morgenstern
`Chief. Project Management Staff
`Division of Cardio‘Ren‘al Drug Products
`Office of Drug Evaluation 1
`Center for Drug Evaluation and Research
`
`a:
`
`1‘.
`
`Orig. NDA
`HFD-1 10 ;.
`DISTRICT OFFlCE
`FD-1 10/ZMcDonal
`
`ACKNOWLEDGEMENT - AC
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`3";me soc anew
`
`June 10, 1997
`
`
`
`-.—_______.
`
`Ohmeda Pharmaceutical Produe
`PO Box 804/110 Allen Road
`Liberty Corner NJ 07938 0804
`see 542 9200
`
`Is Division inc
`
`Food and Drug Adnfirfisu'afion
`1451 RoclwillePike
`5th Floor
`Rockville MD 20852
`
`I
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`
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`.
`
`Attention:
`
`Raymond Lipicky, MD
`Director, Division ofGordie-Renal Drug Products
`
`u;
`
`. —NDA 20-345, Nitric Oxide for Inhalation, 400 ppm
`Submission of a press release to announce N'DA submission
`
`Dear Dr. Lipicky,
`
`Reference is made to a teleconference ofJune 4, 1997 between Ms Zelda McDonald ofthe
`Agency and Ohmeda Pharmaceutical Products Division Inc, (Ohmeda PPD). As discussed
`during the teleconference, Ohmeda PPD plans to submit the NDA on June 16, 1997 and
`would like to announce filing ofthis NDA immediately aflerwards. A copy ofthe
`proposed press release is attached for your review.
`
`release.
`
`Sincerely,
`
`Priya Jambhekar
`Director, Regulatory Afiairs
`
`I.
`
`ene: - Proposed Press Release
`
`
`
`cc:
`
`Zelda McDonald
`Project Manager
`
`

`

`'
`
`'umuy
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`V.
`
`g' / DEPARTMENT OF HEALTH & HUMAN SERVICES
`a. C
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`Public Health Service
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`
`a
`
`
`Food and Drug Administration
`Rockville MD 20857
`
`IND- r
`
`_J .
`
`.
`
`OCT 30 4995
`
`Ohmeda Pharmaceutical Products Division. inc.
`Attention: Mr. Christopher J. Schaber
`110 Allen Road
`
`Liberty Corner, NJ
`
`07938-0804
`
`‘
`
`Dear Mr. Schaber:
`
`Please refer to your investigational new drug applications (INDS) submitted under section
`505(i) of the Federal Food, Drug. and Cosmetic Act for nitric oxide.
`'
`
`'We also reter to the Pre-NDA meeting held on September 27. 1998. between representatives of
`your firm and this Agency. The following represents our summary of the meeting.
`'
`
`J
`
`Background:
`Ohmeda has submitted INDs tor the use of inhaled nitric oxide in the treatment of
`persistent pulmonary hypertension in the neonate (PPHN) and for Acute
`Respiratory Distress Syndrome (ARDS) under INDs
`respectively. At the same time Ohmeda wasoonducting their N01 and N02
`studies, the National Institute of Child Health and Human Development (NICHD)
`was conducting the neonatal inhaled Nitric Oxide Study (NlNOS). The NlNOS was a
`randomized clinical trial using inhaled NO for term and near-term infants with
`hypoxic respiratory failure. The trial was stopped on May 2. 1995 on the
`recommendation of the Data Safety Monitoring Committee since the Committee had
`concluded that the study met the primary outcome without evidence of toxicity.
`Ohmeda subsequently stopped their studies on June 25. 1996 because they found
`they were unable to enroll patients with the NICHD study results known.
`Dr. Wright has agreed that the results of the NINOS may be referred to by FDA in
`support of the Ohmeda application for nitric oxide in PPHN. The purpose of this
`meeting was to discuss the preparation of an NDA for the use of nitric oxide in the
`treatment of persistent pulmonary hypertension in the neonate.
`
`Discussion Pointleecisions/Agreements Reached:
`
`1 .
`
`Does the content of the clinical section. as outlined below. remain
`acceptable to the Agency in support of the neonatal NDA?
`
`Inhaled NO 01 and 02 Studies-
`NlNOS -
`Wessel Study-
`‘
`Roberts Study-
`Inhaled NO 04 and 05 Studies-
`Inhaled NO Literature Review-
`
`'
`
`Full Clinical Report
`Manuscript (as recommended by FDA)
`ManuscriptlAbbreviated Clinical Report
`Manuscript/Abbreviated Clinical Report
`Full Clinical Report
`Reports/Summaries on 1) other neonatal studies
`and 2) non-neonatal studies
`
`I
`
`.-
`
`l
`‘
`
`
`
`

`

`Page 2
`
`M
`
`.
`
`(Studies 04 and 05
`The above outline is acceptable to the Agency.
`are not needed for this NDA. see item #4 below.)
`
`With regard to the NINOS study. the Division requested that the tollowing .
`be submitted to the NINOS IND:
`
`.
`.
`-
`
`-
`-
`
`Full data tape with SAS variables.
`_
`Annotated case report tonne.
`The manuscript that was submitted to the New England Journal of
`Medicine for publication.
`The original protocol and dated set of amendments.
`Accounting of all patients, i.e., all numbers should add up.
`
`The Division requested that Ohmeda‘s NDA contain the following with
`regard to the NO 01 and 02 studies:
`
`.
`.
`-
`
`-
`-
`
`Full data tape with SAS variables.
`Annotated-case report forms.
`Clinical report should consist of the original protocol. dated set of
`amendments and an analysis of the results.
`Accounting of all patients, i.e., all numbers should add up.
`Tabular listing need not be included.
`
`is it necessary tor Ohmeda to have three month stability data on nitric
`oxide-in their to-be-marketed cylinders at the time the NDA is
`submitted?
`
`-
`
`I The Division agreed it would not be necessary.
`
`A strategy for defending the data from NiNOS before an Advisory
`Committee since Ohmeda will have limited access to the predefined
`summary tables. Ohmeda may be unable to answer questions concerning
`"interesting" subgroups ortrends that arise irom close scrutiny of the
`data by FDA.
`
`-
`
`'
`
`Dr. Wright agreed that one of the principal investigators from
`NINQS would present NiNOS before the Advisory Committee.
`
`'The Division believed that there was a high-probability the
`application would be taken before the Advisory Committee.
`
`The possibility 'of providing the'interim study'report for Ohmeda's
`completed phase It ARDS trials (protocols O4 and 05) in the neonatal
`NBA.
`in lieu of a full clinical report (containing safety data only).
`
`-
`
`.
`
`The Division concluded that the ARDS protocols 04 and 05 would
`h_o_t be needed for the PPHN NDA, therefore. the interim report
`would not be needed.
`
`

`

`Page 3
`
`The content and preparation of the integrated summaries of efficacy and
`safety.
`
`-
`
`0
`
`The Division believed that an integrated summary of effigagy
`would not be needed. but some sort- of integrated summary of safety
`wggld be needed.
`
`The firm asked it they could meet with the Division again to
`discuss a strategy for writing an integrated summary of safety.
`and the Division agreed.
`
`The practical issues in attempting to satisfy the August 23, 1996 FDA
`letter wherein the Agency strongly suggested that every effort be made to
`achieve a 0% loss-to~follow-‘up rate for protocols 01 and 02 (N=153).
`
`-
`
`' The Division encouraged the firm to be aggressive in locating all
`patients treated under studies 01 and 02 and obtaining follow-up
`data on them. The Division believed the firm would not have to
`have all the long term outcomes at the time the NDA is submitted
`if
`but a decision would not be made until those data are submitted.
`the application is a “P.“ the firm should be diligent in submitting
`the follow-up data since there'will be only a six month window to
`action.
`If the data are not submitted on time, it is possible the
`Agency would issue a not approvable letter. Although it is not the
`Division's intention to take an action until the follow-up data are
`reviewed,
`if the data are strikingly convincing.
`it is possible the
`application could be approved without long-term data.
`
`The NIH will be issuing a "Clinical Alert" regarding the results of NINOS.
`Does the Division wish to be involved in writing the clinical alert?
`Because of the Clinical Alert, Ohmeda expects that there will be many
`more new investigators. especially from primary care hospitals.
`requesting use of NO who may not be as qualified as earlier investigators
`from tertiary care hospitals. How will the Agency handle such
`investigators?
`
`-
`
`0
`
`The Division would like to be involved in the writing of the
`clinical alert.
`
`The new investigators can obtain their own IND or they can become
`investigators under either Ohmeda's lND or the NINOS lND. The
`Division expressed concern that the Clinical Alert will trigger
`many new lND requests from clinicians Who may be
`underinformed about necessary procedures and precautions for
`
`

`

`Page 4-
`
`use of nitric oxide. Meeting participants agreed that it may be
`useful for NIH to refer.
`in the Clinical Alert. to some sort of
`instruction sheet to- be devised and provided to would-be IND
`holders.
`
`If you have any questions concerning these INDs. please contact:
`
`Ms. Zelda McDonald,
`Regulatory Health Project Manager
`(301)
`594.5333
`
`Sincerely, yours.
`
`Natalia A. Morgenstern
`Chief. Project Management Staff
`Division ot Cardio-Flenal Drug Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`cc:
`
`Original END ’
`
`. F_Q;t_10/ZMcDonald/10/24196
`sb/10f2—9
`
`GENERAL CORRESPONDBJCE
`
`

`

`"H4113!”
`
`I
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`
`"ammwliflll’mductsDivision
`
`Ohmeda Inc
`110 Allen Road PO Box 804
`Liberty Corner NJ 07938 0804
`908 647 9200
`
`October 5. 1994
`
`- Food and Drug Administration.
`HFD-110, Room 168-45
`’
`5600 Fishers Lane
`Rockviile
`MD 20857
`
`Attention: Raymond Lipicky, MD
`Director, Division of Cardio-Renal Drug Products
`
`§
`
`.re:
`
`1ND
`
`inhaled Nitric Oxide (IND)-
`Serial #032 - General Correspondence
`
`Dear Dr Lipicky:
`
`“" _.-.
`
`We thank you for your time in meeting with us. A
`the following background information is attached :
`'
`' Proposed Meeting Agenda/Attendees
`0
`Drug Substance Profile (Attachment I)
`0
`
`'
`
`‘5':
`
`.15:
`as
`I‘.
`iii.
`
`C
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`-
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`
`Drug Product Profile {Attachment ll)
`
`Drug Substance/Product Analytical Controls (Attachméfifiii)
`
`Drug SLibstance/Product Stability (Attachment IV)
`
`Environmental Assessment {Attachment V)
`
`0
`
`0
`0
`
`Formerly Anaouesl inc
`
`
`

`

`Raymond Lipicky, MD
`" October 5, 1994
`Page 2
`
`If you have Ham/questions prior to the meeting. please contact me at
`(908) 604-7704 or Steven Pikulin at (908) 604-7703.
`
`SincerelyYours,
`
`"
`
`/m 2.91%; Fae
`
`Robert I. Outwater
`Senior DirectorpyVorldwide Regulatory Affairs
`
`
`
`Desk Capies:
`
`Dr Walters _
`Dr Cunningham
`
`enc: Form FDA 1571
`
`SP:ab
`
`

`

`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`PUBLIC HEALTH SERVICE
`FOOD AND DRUG ADMINISTRATION
`INVESTIGA'IIOIIAL NEW onus APPLICATION (IN I
`- ., mnrzr. cone or renew REGULATIONS (cm em :12)
`
`
`
`
`I
`
`IN 0'
`
`
`FormW: OMB No. 0.9 I'D-OOH.
`
`Exam Iron De Ie : November 30. I995.
`
`
`See OMB Sn Iemen: on serene.
`
`
`
`
`
`NOTE: No drug may be ”upped or dlmul
`
`Invemgmon begun mm! on IND Ior that
`
`mnrugmon II In eflen (21 CPR 31210)
`'A‘
`
`
`
`2 DATE OF SUBMISSION
`
`
`Ohmeda Pharmaceutical Products Division Inc
`
`
`19%
`October 5
`
`
`3. ADDRESS (Number, Street, Cnmee endZIp Code)
`I TELE'HONE NUMBER
`
`
`(Mode Aru Code}
`110 Allen-Road
`
`
`Liberty Corner
`_
`NJ 07938 0804‘
`
`
`
`908/604-7705
`
`
`
`
`5. NAMEIS) OF DRUG (Include eIIeuI'IabIe names: rude. Generic. Chemical; Code)
`
`. IND NUMBER I previously “up"; .
`Nitric oxide
`
`
`
` 7. INDICATIONISJICo-Ieredby this warnInI‘On) _
`
`
`Persistent Pulmonary Hypertension in the Newborn (PPHN) and Acute Respiratory
`
`Distress Syndrorne (ARDS)
`
`
`
`9 LIST NUMSERS OF ALL INVES‘TTOAIIONAL NEW onus APPLICATIONS {2: CM Pan .1 I2). NEW DRUG DR AN‘IIIIOTIC APPLICATIONS
`{2! CHI Pen 3“). DRUG MAST“. FILES {2! CFR J" 42w. {IND PRODUCT LICENSE APPLICATIONS (2’ CFR hr! GOIJ flE FERRED 70 IN THIS
`APPLICATION.
`-
`.
`
`
`
`5. PHASE moscLummmvrsnomou IDBECONDUCTED:DPHASE1 menus:
`
`amuse: Domes
`
`
`
` (Specify)
`
`
`
`
`
`
`Io. IND submissrons shouldbe consecutively numbered. The initial IND shouIdbe numbered
`
`SERIAL NUMBER:
`'Sen'al Numb-er: 000. " The next submimon (e.g.. amendment. report. or correspondence)
`
`
`
`97on be numbered 'Sen'al Number: 00!. ' SubsequenIsubI-nissions should be numbered
`
`0 3 2
`consecutively In the order in which they are summed." -’~
`‘
`
`
`
`
`11. THIS SUBMISSION CONTAINS 'IHI: FOLLOWING: (Check eIItheuppM
`
`D INITIAL INVESTIGATIONAL NEW DRUG APPLICATION (IND)
`
`- D RESPONSE To CLINICAL HOLD
`
`PROTOCOL AMENDME NTIS):
`a NEW PROTOCOL
`CI CHANGE IN PROTOCOL
`0 NEWIIIVESTIGATOR
`
`INFORMATION AME NDMENTISI:
`u CHEMISTRYMICROIIOLOGT
`L1 PHARMACOLOGTNOXICOLOGY
`D CLINICAL ‘
`
`.
`
`'
`
`IND SAFETY REPORTISI:
`. D mnmwmnmuwn
`Cl Fouow.up TD ‘ WRITTEN upon
`
`
`
`
`
`
`
`
`
`
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`I! THEIOCGRDU‘P
`
`Ohmeda Pharmaceutical Products Division Inc
`PO Box 804 I110 Allen Road
`Liberty Carner NJ 07938 0804
`900 647 9200
`
`Ms. Priya Jambhekar
`Director. Regulatory Affairs
`Ohmeda Pharmaceutical Products Division Inc.
`1 10 Allen Road
`Liberty Corner. New Jersey 07938-0004
`
`'
`
`June 10. 1997
`
`‘
`
`Re:
`
`Patent Certification - l-l\i0m (Nitric Oxide)
`Ohmeda Pharmaceutical Products Division inc.
`Our Ref. PA#V10
`‘
`'
`
`Dear Ms. Jambhekar:
`
`
`
`is the exclusive
`This is to certify that Ohmeda Pharmaceutical Products Division Inc.
`licensee for the rights to the administration of Nitric Oxide by inhalation for the
`prevention and treatment of reversible pulmonary vasoconstriction. These rights.
`were acquired from the General Hospital Corporation of Boston, Massachusetts under
`the following U.S. Patent:
`
`LLS, Patent No. 5.585.322 which-claims prevention or treatment of reversible
`pulmonary vasoconstriction by the inhalation of nitric oxide with an oxygen-
`containing gas. This patent expires January 23, 2013.
`'
`
`If you require additional information with regard to the U.S. patent discussed herein,
`please so advise me.
`
`Very truly yours,
`
`@7
`
`R. Hain Swope
`Patent Counsel
`
`
`
`
`
`0079 0|,
`
`
`