CENTER FOR DRUG EVALUATION AND
`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`21-2 72
`
`MICROBIOLOGY REVIEW
`
`
`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`21-2 72
`
`MICROBIOLOGY REVIEW
`
`
`
`REVIEW TO HFD 110
`
`OFFICE OF NEW DRUG CHEMISTRY
`
`Microbiology Staff, HFD-805
`Microbiologist’s Review #3 of
`Supplement
`March 28, 2001
`
`NBA:
`
`21-272/N-BI
`
`APPLICANT/SPONSOR:
`
`United Therapies Corporation
`68 T.W. Alexander Dr.
`
`Research Triangle Park, NC 27709
`
`Contact:
`
`Dean Bunce
`
`Associate Director,
`Regulatory Affairs
`919-485-8350
`
`MANUFACTURING SITE:
`
`W
`
`DRUG PRODUCT NAME
`
`Proprietary:
`Nonpropn'etary:
`Drug Priority Classification:
`
`Uniprost (UT-15)
`Triprostinol Sodium (applied for)
`Standard
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY:
`
`Subcutaneous injection
`1.0, 2.5, 5.0, and 10 mg/mL
`
`0
`
`METHOD! S) OF STERILIZATION: m
`
`PHARMACOLOGICAL CATEGORY AND/OR PRINCIPLE INDICATION:
`
`PP’Nt‘
`
`9'
`
`DOCUMENT/LETTER DATE:
`
`RECEIPT DATE:
`
`CONSULT DATE:
`
`DATE OF AMMENDMENT:
`
`ASSIGNED FOR REVIEW:
`
`pulmonary arterial hypertension
`
`August 11, 2000
`August 14, 2000
`August 16, 2000
`February 19, 2001 (Subject of this
`review)
`March 28, 2001
`
`
`
`6.
`
`SUPPORTmG/RELATED DOCUMENTS:
`
`Review #1 of this supplement was completed on October 26, 2000. A
`deficiency letter was sent on November 6, 2000. A teleconference was held on
`February 1, 2000 with Dean Bunce and several representatives of United
`Therapeutics Corporation to discuss the.
`‘
`‘vials.
`
`REMARKS:
`
`Uniprost (UT-15) has been designated as an orphan drug for
`the treatment of pulmonary arterial hypertension. The
`following is a review of the applicant’s responses to the
`microbiology deficiencies listed in the first review.
`
`CONCLUSIONS:
`
`The submission is recommended for approval from the
`
`standpoint of microbial promuality.
`
`Stephen E. Langille, Ph. D.
`
`CC:
`
`Original NDA-Zl-272
`HFD-l 10/Division File
`
`HFD-l lO/ChemJAdvani
`
`HFD 805/Consult File/Langille
`Drafied by S. Langille czreviews/21-272r3
`Initialed by P. Cooney
`
`
`
`
`
`
`
`2 page(s) have been
`removed because it
`
`contains trade secret
`
`and/or confidential
`
`information that is not
`
`disclosable.
`
`'
`
`
`
`
`
`
`
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`Stephen Langille
`4/19/01 11:33:10 AM
`MICROBIOLOGIST
`
`_V
`Peter Cooney
`4/19/01 01:40:09 PM
`MICROBIOLOGIST
`
`
`
`REVIEW TO HFD 110
`
`OFFICE OF NEW’DRUG CHEMISTRY
`
`Microbiology Staff, HFD-805
`Microbiologist’s Review #2 of Supplement
`March 5, 2001
`
`NBA:
`
`21-272/N-000-C
`
`APPLICANTISPONSOR:
`
`v United Therapies Corporation
`68 T.W. Alexander Dr.
`
`Research Triangle Park, NC 27709
`
`Contact:
`
`Dean Bunce
`
`Associate Director,
`
`Regulatory Affairs
`919-485-8350
`
`MANUFACTURING SITE: M
`
`DRUG PRODUCT NAME
`
`Proprietary:
`Nonproprietary:
`Drug Priority Classification:
`
`Uniprost (UT-15)
`Triprostinol Sodium (applied for)
`Standard
`
`
`DOSAGE FORM ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY:
`
`Subcutaneous injection
`1.0, 2.5, 5.0, and 10 mg/mL
`
`0
`
`METHOD! S} OF STERILIZATION: w
`
`PHARMACOLOGICAL CATEGORY AND/OR PRINCIPLE INDICATION:
`
`pulmonary arterial hypertension
`
`9:59.“?
`
`DOCUMENT/LETTER DATE:
`RECEIPT DATE:
`CONSULT DATE:
`DATE OF AMMENDMENT:
`
`ASSIGNED FOR REVIEW:
`
`August 11, 2000
`August 14, 2000
`August 16, 2000
`November 10, 2000 _
`
`November 15, 2000
`
`SUPPORTING/RELATED DOCUMENTS:
`
`
`
`Review #1 of this supplement was completed on October 26, 2000. A
`deficiency letter was sent on November 6, 2000. A teleconference was held on
`February 1, 2000 with Dean Bunce and several representatives of United
`Therapeutics Corporation to discuss the
`~ _
`_
`*vials. In a letter
`to the FDA dated February 19, 2001, United Therapeutics Corporation
`agreed to
`‘ all vials during commercial production of
`UT-lS.
`
`C.
`
`REMARKS:
`
`Uniprost (UT~15) has been designated as an orphan drug for
`the treatment of pulmonary arterial hypertension. The
`following is a review of the applicant’s responses to the
`microbiology deficiencies listed in the first review.
`
`D.
`
`CONCLUSIONS:
`
`The submission is recommended for approval from the
`
`standpointofmicrobial producigi’lity.
`
`Stephen E. Langille, Ph. D.
`
`cc:
`
`Original NDA-Zl-272
`HFD-l lO/Division File
`
`HFD-l lO/ChemJAdvani
`
`HFD SOS/Consult File/Langille
`Drafied by S. Langille czreviews/21-272r2
`Initialed by P. Cooney
`
`E. REVIEW NOTES:
`
`
`
`
`
`5 page(s) have been
`removed because it
`
`contains trade secret
`
`'
`
`and/or confidential
`
`information that is not
`
`disclosable.
`
`'
`
`
`
`
`
`Stephen Langille
`3/6/01 09:14:48 AM
`MICROBIOLOGIST
`
`Peter Cooney
`3/6/01 01:41:09 PM
`MICROBIOLOGIST
`
`
`
`
`
`’
`REVIEW TO HFD 110
`OFFICE OF NEW DRUG CHEMISTRY
`
`'
`
`FKOHH
`OCT 2 6 2000
`
`Microbiology Staff, HFD-805
`Microbiologist’s Review #1 of Supplement
`October 24, 2000
`
`EDA:
`
`21-272
`
`W: 7
`'
`
`United Therapies Corporation
`68 T.W. Alexander Dr.
`
`Research Triangle Park, NC 27709
`
`Contact:
`
`Dean Bunce
`
`Associate Director,
`
`Regulatory Affairs
`919—485-8350
`
`
`
`‘W ‘ ‘ _ "M
`
`
`
`Uniprost (UT-15)
`Triprostinol Sodium (applied for)
`Standard
`
`W P
`
`roprietary:
`Nonproprietary:
`Drug Priority Classification:
`
`
`
`o Subcutaneous injection
`1.0, 2.5, 5.0, and 10 mg/mL
`
`W: .N
`
`W p
`
`ulmonary arterial hypertension
`
`W August 1 l, 2000
`W _,
`.
`_.
`August 14, 2000
`W August 16, 2000
`
`AW August 22, 2000
`
`99:59.“?
`
`
`
`I
`
`C.
`
`REMARKS:
`
`Uniprost (UT-15) has been designated as an orphan drug for
`the treatment of pulmonary arterial hypertension.
`
`D.
`
`CONCLUSIONS:
`
`The submission is approvable pending resolution of
`microbiological deficiencies. Specific comments regarding the
`. ~‘jprocess are provided in "E. Review Notes" and
`"List of Microbiology Deficiencies and Comments".
`
`‘/
`
`___/0 *ZY‘oo
`,_ E‘
`Tepfen’fijang'ine’, Ph. D.
`cl W m I”)
`l a
`‘
`
`‘"
`
`I
`
`-
`Original NDA-Zl-272
`
`‘
`
`cc:
`
`HFD-l lO/Division File
`
`'
`
`HFD—l 10/Chem./Advani
`
`I-IFD SOS/Consult File/Langille
`Dfafied by S. Langille v:microrev\# 21~272rl
`Initialed by P. Cooney
`
`
`
`
`
`/5 page(s) have been
`removed because it
`
`contains trade secret
`
`.
`
`and/or confidential
`
`._
`
`information that is not
`
`disclosable.
`
`'
`
`
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