LACHMAN CONSULTANT SERVICES, INC.
`CONSlJL TANTS TO THE PHARMACEUTICAL AND ALLIED INDUSTRIES
`
`1600 STEWART AVENUE, WESTBURY, NY 11590
`(516) 222-6222 • FAX (516) 683-1887
`
`0 1 1 7 12 SEP 28 A11 :05
`
`September 27, 2012
`
`OVERNIGHT COURIER 9/27/2012
`
`Division of Dockets Management
`Food and Drug Administration
`Department of Health and Human Services (HFA-305)
`5630 Fishers Lane, Room 1061
`Rockville, MD 20852
`
`Dear Sir or Madam:
`
`CITIZEN PETITION
`
`Lachman Consultant Services, Inc. (Lachman) is submitting this Citizen Petition in quadruplicate pursuant
`to 21 CFR 10.30 and in accordance with the regulations of 21 CFR 314.161, on behalf of a client, to
`request that the Commissioner of the Food and Drug Administration determine whether a listed drug has
`been voluntarily withdrawn for safety or effectiveness reasons as outlined below.
`
`A. Action Requested
`
`The petitioner requests that the Commissioner of the Food and Drug Administration determine whether
`SUBOXONE® (buprenorphine hydrochloride and naloxone hydrochloride) Sublingual Tablets, 2 mg/0.5
`mg and 8 mg/2 mg 1 have been voluntarily withdrawn from sale for safety or efficacy reasons.
`
`B. Statement of Grounds
`
`The Food and Drug Administration maintains a list of drug products which are eligible for submission as
`abbreviated new drug applications in the Approved Drug Products with Therapeutic Equivalence
`Evaluations
`("The Orange Book").
`SUBOXONE® (buprenorphine hydrochloride and naloxone
`hydrochloride) Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg, by Reckitt Benckiser were approved by
`the FDA on October 8, 2002 under NDA 20~733. Upon approval, SUBOXONE® Sublingual Tablets, 2
`mg/0.5 mg and 8 mg/2 mg, were considered to be "listed drug products" by virtue of their listing in the
`Orange Book. While the electronic Orange Book, accessed on September 27, 2012 (current through
`August 2012) still lists SUBOXONE® Sublingual Tablets as an actively marketed product, Reckitt
`Benckiser has publicly announced that the sublingual tablet dosage form is being discontinued in favor of
`the sublingual film dosage for which the company holds a separate, approved application (NDA 22-41 0).
`(Refer to Attachment 1 ).
`
`Under FDA regulations, drugs are withdrawn from the market if the Agency withdraws or suspends
`approval of the drug application for the reasons of safety or effectiveness, or if the FDA determines that
`the listed drug was withdrawn or withheld from sale for reasons of safety or effectiveness (21 CFR
`314.162). The regulations also provide that the Agency must make a determination as to whether a listed
`drug is withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed
`drug may be approved (21 CFR 314.161(a)(1)).
`
`1
`
`Each strength contains the labeled amount of buprenorphine base and naloxone base.
`
`P D A-cJO[ Q- Y ... JQjt/www.lachmanconsultants.com
`
`LCS@lachmanconsultan~.com
`
`Page 1
`
`

`

`LACHMAN CONSULTANT SERVICES, INC.
`Westbury, NY 11590
`
`Division of Dockets Management
`Food and Drug Administration
`September 27, 2012
`Page 2 of 2
`
`Lachman acknowledges that the announcement by Reckitt Benckiser states that its decision to
`discontinue sale of SUBOXONE® Sublingual Tablets is related to a higher risk of children gaining access
`to the tablets as compared to the film due to differences in packaging configuration. It does not, however,
`suggest that the tablet dosage form itself is unsafe or less safe than the film dosage form for use by the
`intended patient population. Moreover, since determinations regarding whether a drug product was
`discontinued for safety or efficacy reasons, for purposes of evaluating approvability of an ANDA that
`identifies that product as the Reference Listed Drug (RLD) are the responsibility of the Food and Drug
`Administration, the announcement by Reckitt Benckiser cannot be relied upon for this purpose.
`Therefore, Lachman respectfully requests that the Food and Drug Administration make the requisite
`determination as to whether SUBOXONE® Sublingual Tablets were discontinued from sale for safety or
`efficacy reasons; in order to enable action on any ANDAs that are presently pending approval and refer to
`SUBOXONE® Sublingual Tablets as the RLD.
`
`C. Environmentallmpact
`
`A claim for categorical exclusion of the requirements for an environmental assessment is made pursuant
`to 21 CFR 25.31.
`
`D. Economic Impact
`
`Pursuant to 21 CFR 10.30(b), economic impact information is submitted only when requested by the
`Commissioner. This information will be promptly provided, if so requested.
`
`E. Certification
`
`The undersigned certifies that, to the best knowledge and belief of the undersigned, this petition includes
`all information and views on which the petition relies, and that it includes representative data and
`information known to the petitioner, which is unfavorable to the petition.
`
`Respectfully submitted,
`
`~~~~
`Vice Presid~~~
`
`1-'
`
`JJ/pk
`
`Attachments: Chicago Tribune article, dated September 25, 2012, announcing discontinuation of
`SUBOXONE® Sublingual Tablets by Reckitt Benckiser
`
`cc:
`
`Martin Shimer (Office of Generic Drugs)
`
`M33_Petition Suboxone Tabs SandE Determination
`
`www.lachmanconsultants.com
`
`LCS@J.a.chmanconsultants.com
`
`Page 2
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`

`

`Origin ID: RMEA
`
`(516) 683-1881
`From:
`Westbury Office
`LACHMAN CONSULT ANT SERVICES
`1600 STEWART AVE
`SUITE 604
`WESTBURY, NY 11590
`
`J 12201207160325
`BILL SENDER
`SHIP TO: (301) 827-6860
`Division of Dockets Management
`FDA, DHHS, HFA-305
`5630 FISHERS LN RM 1061
`
`ROCKVILLE, MD 20852
`
`Page 1 of2
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`Ship Date: 27SEP12
`ActWgt 1. 0 LB
`CAD: 1879030/INETJJOO
`
`Delivery Address Bar Code
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`llllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllll
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`Citizen Petition
`
`Ref#
`Invoice#
`PO#
`Dept#
`
`TRK# 7990 697 4 9328
`I 0201 I
`
`ZD OBTA
`
`FRI- 28 SEP A1
`STANDARD OVERNIGHT
`DSR
`20852
`lAD
`
`MD-US
`
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`9/27/2012
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