3g DEPARTMENTOFHEALTH & HUMANSERVICES
`
`Pub'ic“93““Service
`
`Food and Drug Administration
`Rockville, MD 20857
`
`IND 70,362
`
`Lung Rx, Inc.
`Attention: Mr. Ted Staub
`
`107? Highway AlA
`Satellite Beach, FL 32937
`
`Dear Mr. Staub:
`
`We acknowledge receipt of your Investigational New Drug Application (IND) submitted under
`section 505(i) of the Federal Food, Drug, and Cosmetic Act. Please note the following
`identifying data:
`
`IND Number Assigned:
`
`70,362
`
`Sponsor:
`
`Lung Rx, Inc.
`
`Name of Drug:
`
`Treprostinil sodium
`
`Date of Submission:
`
`March 28, 2005
`
`Date of Receipt:
`
`March 29, 2005
`
`Studies in humans may not be initiated until 30 days after the date of receipt shown above.
`or before April 28, 2005, we identify deficiencies in the IND that require correction before
`human studies begin or that require restriction of human studies, we will notify you immediately
`that (I) clinical studies may not be initiated under this IND (“clinical hold”) or that (2) certain
`restrictions apply to clinical studies under this IND (“partial clinical hold”). In the event of such
`notification, you must not initiate or you must restrict such studies until you have submitted
`information to correct the deficiencies, and we have notified you that the information you
`submitted is satisfactory.
`
`If, on
`
`It has not been our policy to object to a sponsor, upon receipt of this acknowledgement letter,
`either obtaining supplies of the investigational drug or shipping it to investigators listed in the
`IND. However, if the drug is shipped to investigators, they should be reminded that studies may
`not begin under the IND until 30 days after the IND receipt date or later if the IND is placed on
`clinical hold.
`
`UNITED THERAPEUTICS, EX. 2052
`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017-01621
`
`Page 1 of4
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`

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`IND "£0,362
`
`Page 2
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`As sponsor of this IN D, you are responsible for compliance with the Federal Food, Drug, and
`Cosmetic Act and the implementing regulations (Title 21 of the Code of Federal Regulations).
`Those responsibilities include (I) reporting any unexpected fatal or life-threatening adverse
`experience associated with use of the drug by telephone or fax no later than 7 calendar days after
`initial receipt of the information [2] CFR 3 I 232(c)(2)]; (2) reporting any adverse experience
`associated with use of the drug that is both serious and unexpected in writing no later than 15
`calendar days after initial receipt of the information [21 CFR 312.32(c)(1)]; and (3) submitting
`annual progress reports [21 CFR 312.33].
`
`As required by the Food and Drug Modernization Act and the Best Pharmaceuticals for Children
`Act, you are also responsible for registering certain clinical trials involving your drug product in
`
`the Clinical Trials Data Bank (http:r’fclinicaltrialsgov & http:r’r‘prsinfo.clinicaltrials.govr’). If your
`drug is intended for the treatment of a serious or life-threatening disease or condition and you are
`conducting clinical trials to test its effectiveness, then you must register these trials in the Data
`Bank. Although not required, we encourage you to register effectiveness trials for non-serious
`diseases or conditions as well as non-effectiveness trials for all diseases or conditions, whether or
`not they are serious or life-threatening, Additional information on registering your clinical trials,
`including the required and optional data elements and the FDA Draft Guidance for Industry,
`“Information Program on Clinical Trials for Serious or Life-Threatening Diseases and
`Conditions,” is available at the Protocol Registration System (PRS) Information Site
`htm:fr’prsinfoclinicaltrialsgovf.
`
`Please forward all future communications concerning this IND in triplicate, identified by the
`above IND number, to either of the following addresses:
`
`US. Postal Service:
`
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Cardio—Renal Drug Products, HFD-l 10
`Attention: Division Document Room, 5002
`5600 Fishers Lane
`
`Rockville, Maryland 20857
`
`Courierr'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, 5002
`1451 Rockville Pike
`
`Rockville, Maryland 20852
`
`UNITED THERAPEUTICS, EX. 2052
`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017-01621
`
`Page 2 of4
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`

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`IND "£0,362
`
`Page 3
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`If you have any questions, please call:
`
`Mr. John David
`
`Regulatory Health Project Manager
`(301) 594-5309
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Edward Fromm
`
`Chief, Project Management Staff
`Division of Cardio—Renal Drug Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`UNITED THERAPEUTICS, EX. 2052
`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017-01621
`
`Page 3 of4
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`

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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.
`
`
`
`Edward Fromm
`
`4/13/05 10:02:46 AM
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR2017-O1621
`
`UNITED THERAPEUTICS, EX. 2052
`
`Page 4 of 4
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