Pending Monographs

Pending Monographs

USP provides Pending Monographs for certain drug products, drug substances, and excipients that have been submitted or are intended to be submitted to the U.S. Food and Drug Administration (FDA) for approval to be marketed in the United States, but have not yet received such approval. Under this approach, sponsors of Requests for Revision such as manufacturers of generic or over˗the˗counter (OTC) products and others can work with USP to propose new monographs or to propose revision to existing text. Once FDA approval is granted, USP then works with the sponsor to move the new monograph or revision to existing text into official USP–NF status, along with an official USP Reference Standard where appropriate.

Details of the approach are described in the Pending Monographs Guideline Version 3.0 (effective June 1, 2015).

USP will be reevaluating all of the Draft Monographs and Authorized Pending Monographs that are currently posted below. If no longer relevant, these monographs will be eliminated. Where there is a desire to move these monographs forward to official status, they will be developed, balloted, and published in accordance with the revised Pending Monograph Guideline, including publication in Pharmacopeial Forum (PF) where required under the Guideline. This process is expected to take several months.

Beginning June 26, 2015, the tables of pending proposals currently posted on the Pending Monograph webpage will be updated monthly to indicate which monographs were removed from the website and whether they were eliminated or proposed in PF.

For additional information, contact Michael Goede (myg@usp.org).

Latest Updates to Draft Monographs  (updated 25–Mar–2016; next posting 27–May–2016)

Monograph

Date Posted

Status

Liaison

History

Ibandronate Sodium

Nov. 24, 2010

Draft proposal cancelled because of significant negative comments received.Elena Gonikberg (eg@usp.org)Draft posted on Nov. 24, 2010, comment period ended Feb 28, 2011. Proposal cancelled on Mar. 25, 2016

Zoledronic Acid

Aug. 27, 2010

Draft proposal cancelled, because of significant negative comments received.Elena Gonikberg (eg@usp.orgDraft posted on Aug 27, 2010, comment period ended Nov. 30, 2010. Proposal cancelled on Mar. 25, 2016

Latest Updates to Draft Monographs  (updated 25–Mar–2016; next posting 27–May–2016)

Monograph

Date Posted

Status

Liaison

History

AripiprazoleOct. 26, 2012Pending Revision Cancelled. No impact on official USP–NF monograph

Heather Joyce (hrj@usp.org)

Cancelled on Mar. 25, 2016

 

Draft Monographs — Previous Postings

Monograph

Date Posted

Status

Liaison

History

Abiraterone AcetateSep. 27, 2013Draft 1Feiwen Mao (fm@usp.org) 
Azacitidine for InjectionJun. 28, 2013Draft 1, comment period ends Sep. 30, 2013.Ramanujam Prasad  (rsp@usp.org)
Brimonidine TartrateMar. 28, 2014Draft 1Feiwen Mao (fm@usp.org) 
Colesevelam HydrochlorideAug. 31, 2012Draft 1, comment period ended Nov. 30, 2012. Awaiting Expert Committee approval.Sujatha Ramakrishna (sxr@usp.org) 
DecitabineJun. 4, 2014Draft 1Feiwen Mao (fm@usp.org) 

Ibandronate Sodium

Nov. 24, 2010

Draft proposal cancelled because of significant negative comments received

Elena Gonikberg ( eg@usp.org )

Draft posted on Nov. 24, 2010, comment period ended Feb 28, 2011. Cancelled on Mar. 25, 2016 

Iron Sucrose Injection

N/A

Withdrawn at sponsor's request.

Sujatha Ramakrishna (sxr@usp.org)

 
Lamivudine, Zidovudine, and Nevirapine TabletsNov. 30, 2012Draft 2, comment period ended Feb. 28, 2013. Awaiting Expert Committee approval.Amanda Martin-Esker (ame@usp.org)
LatanoprostMar. 30, 2012Draft 1, comment period ended Jun. 30, 2012. Awaiting Expert Committee approval.Feiwen Mao (fm@usp.org)
Latanoprost Ophthalmic SolutionMar. 30, 2012Draft 1, comment period ended Jun. 30, 2012. Awaiting Expert Committee approval.Feiwen Mao (fm@usp.org)
Oxiconazole NitrateDec. 27, 2013Draft 1Shankari Shivaprasad (sns@usp.org)

PaliperidoneMay 25, 2012Pending Revision Cancelled. No impact on official USP–Nf monograph.Ravi Ravichandran (rr@usp.org)

Revision cancelled on Nov. 20, 2015

Rabeprazole SodiumFeb. 22, 2013Elena Gonikberg (eg@usp.org)Proposed in PF 41(2) [Mar.–May 2015]
RanolazineOct. 25, 2013Draft 1Sujatha Ramakrishna (sxr@usp.org)

Ribavirin Tablets

N/A

See Pending Monographs Advancing to USP – NF section below

Leonel Santos ( lxs@usp.org )

Ribavirin Tablets Draft 1

Tolterodine Tartrate

N/A

Withdrawn at sponsor's request.

Elena Gonikberg (eg@usp.org)

 

Valacyclovir Hydrochloride

May 28, 2010

See Pending Monographs Advancing to USP–NF section below.

Behnam Davani (bd@usp.org)

Valacyclovir Hydrochloride 

Ziprasidone HydrochlorideDec. 28, 2011Official Dec. 1, 2012, via Revision Bulletin.Ravi Ravichandran (rr@usp.org)Published in Revision Bulletin, Nov. 30, 2012

Zoledronic Acid

Aug. 27, 2010

Draft proposal cancelled because of significant negative comments received

Elena Gonikberg (eg@usp.org)

Draft posted on Aug. 27, 2010, comment period ended Nov. 30, 2010. Cancelled Mar. 25, 2016 

 

Authorized Pending Monographs — Previous Postings

Monograph

Date Posted

Status

Liaison

History

Abacavir Oral Solution

Feb. 29, 2008

Authorized V.1

Behnam Davani (bd@usp.org)

Abacavir Sulfate

Mar. 26, 2010

Authorized V.2

Leonel Santos ( lxs@usp.org )

Abacavir Sulfate V.1

Abacavir Tablets

Oct. 30, 2009

Authorized V.1

Leonel Santos ( lxs@usp.org )

          —

Acamprosate CalciumDec. 27, 2013Authorized V.1Heather Joyce (hrj@usp.org) 

Almotriptan Malate

Sept. 30, 2011

Authorized V.2

Heather Joyce (hrj@usp.org)
Almotriptan Malate V.1

Almotriptan Tablets

Apr. 30, 2010

Authorized V.1

Heather Joyce (hrj@usp.org)

Amlodipine and Benazepril Hydrochloride Capsules      Aug. 26, 2011 Authorized V.1Sujatha Ramakrishna (sxr@usp.org)

Anastrozole

Oct. 30, 2009

Authorized V.1

Feiwen Mao
(fm@usp.org)

 

Aripiprazole Oct. 26, 2012Pending Revision Cancelled. No impact on official USP–NF monographHeather Joyce (hrj@usp.org)Mar. 25, 2016
Aprepitant

Jun. 29,
2012

Published in USP 39–NF 34, official May 1, 2016Elena Gonikberg (eg@usp.org)Revision incorporated in USP–NF
Atomoxetine HydrochlorideDec. 28, 2011Authorized V.1Heather Joyce (hrj@usp.org)
Atorvastatin CalciumFeb. 24, 2012See Pending Monographs Advancing to USP–NF section below.Elena Gonikberg (eg@usp.org)

Atorvastatin Calcium V.1

Azacitidine

Jun. 29,
2012

Authorized V.1Feiwen Mao (fm@usp.org)

Bemotrizinol

Jan. 30,
2009

Authorized V.2

Feiwen Mao (fm@usp.org)

Bemotrizinol V.1

BosentanDec. 28, 2012Authorized V.1Domenick Vicchio (dwv@usp.org)

         —          

Bupropion HydrbromideApr. 26, 2013Authorized V.1Heather Joyce (hrj@usp.org)
CabergolineApr. 26, 2013See Pending Monographs Advancing to USP–NF section below.Heather Joyce (hrj@usp.org)Cabergoline V.1

Cefditoren Pivoxil

Jun. 26,
2009

Authorized V.1

Ahalya Wise (aww@usp.org)

 

ClimbazoleOct. 28, 2011Authorized V.1Feiwen Mao (fm@usp.org)
DalfampridineDec. 27, 2013Authorized V.1Heather Joyce (hrj@usp.org)New proposal published in PF 42(1)[Jan.-Feb. 2016]
Didanosine Tablets for Oral SuspensionFeb. 24, 2012Authorized V.1Behnam Davani (bd@usp)

   

Donepezil Hydrochloride Tablets

Feb. 29, 2008

Incorporated in USP 35–NF 30, First Supplement

Heather Joyce ( hrj@usp.org )

Official via Revision Bulletin (posted 29–Jul–2011; official 01–Aug–2011)

Drometrizole Trisiloxane

Apr. 29, 2011

Authorized V.1

Feiwen Mao (fm@usp.org)

 

Efavirenz

Feb. 29, 2008

Authorized V.1

Behnam Davani (bd@usp.org)

 

Efavirenz Capsules

Oct. 30, 2009

Authorized V.1

Leonel Santos ( lxs@usp.org )

 

Efavirenz Tablets

Oct. 30, 2009

Authorized V.1

Leonel Santos ( lxs@usp.org )

 

Emtricitabine

Dec. 29, 2010

Authorized V.1, updated Feb. 27, 2015 to correct chemical name in Table 1

Shankari Shivaprasad (sns@usp.org)

 

Emtricitabine Capsules

Dec. 29, 2010

Authorized V.1

Shankari Shivaprasad (sns@usp.org)

 

Eprosartan MesylateApr. 26, 2013Authorized V.1Sujatha Ramakrishna (sxr@usp.org)

Escitalopram Tablets 

May 29, 2009

Authorized V.1

Heather Joyce (hrj@usp.org)

 

Escitalopram Oral SolutionApr. 27, 2012See Pending Monographs Advancing to USP–NF section below.Heather Joyce (hrj@usp.org) Escitaopram Oral Solution V.1

Escitalopram Oxalate

Apr. 30, 2010

Authorized V.2

Heather Joyce (hrj@usp.org)

Escitalopram Oxalate V.1.1

Esomeprazole Magnesium   

Dec. 29, 2010

Official Dec. 1, 2015

Elena Gonikberg (eg@usp.org)

 

Published in Revision Bulletin, Nov. 20, 2015
EszopicloneSep. 30, 2011Authorized V.1

Heather Joyce (hrj@usp.org)

Ethylhexyl Triazone

Feb. 29, 2008

Authorized V.1

Feiwen Mao (fm@usp.org)

EtonogestrelDec. 27, 2013Authorized V.1Domenick Vicchio (dwv@usp.org) 

Exemestane

Dec. 29, 2010

Authorized V.1

Feiwen Mao (fm@usp.org)

 

Famciclovir Tablets

Apr. 30, 2010

Authorized V.1

Behnam Davani (bd@usp.org)

 

Frovatriptan SuccinateDec. 27, 2013Authorized V.1Heather Joyce (hrj@usp.org)Proposed in PF 41(5) [Sep.–Oct. 2015]

Gatifloxacin

Apr. 30, 2010

Authorized V.2

Behnam Davani (bd@usp.org)

Gatifloxacin V.1

Ictasol

Apr. 29, 2011

Authorized V.1

Feiwen Mao (fm@usp.org)

 

 
IscotrizinolFeb. 28, 2014Authorized V.1Feiwen Mao (fm@usp.org) 

Imiquimod Cream

Apr. 29, 2011

Authorized V.1

Behnam Davani (bd@usp.org)

 

Lamivudine

Oct. 30, 2009

Authorized V.1

Behnam Davani (bd@usp.org)

 

Lamivudine Oral Solution

Mar. 26, 2010

Authorized V.1

Behnam Davani (bd@usp.org)

 

Lamivudine and Stavudine Tablets  

Feb. 25, 2011

Authorized V.1

Behnam Davani (bd@usp.org)

 

Lamivudine Tablets  

Aug. 29, 2008

Authorized V.1

Behnam Davani (bd@usp.org)

 

Lamivudine, Zidovudine, And Nevirapine Tablets  

Mar. 26, 2010

Authorized V.1

Behnam Davani (bd@usp.org)

 

Lamivudine and Zidovudine Tablets  

Feb. 25, 2011

Authorized V.1

Behnam Davani ( bd@usp.org )

 

Lamotrigine

Nov. 23, 2007

Pending Revision Cancelled. No impact on official USP–Nf monograph.

Ravi Ravichandran ( rr@usp.org )

Proposal was cancelled on June 26, 2015

Levofloxacin

Jan. 30,
2009

Authorized V.2

Behnam Davani (bd@usp.org)

Levofloxacin V.1

Levofloxacin Tablets

Apr. 29, 2011

Authorized V.1

Behnam Davani (bd@usp.org)

 

LinezolidMar. 29, 2013Authorized V. 1Ahalva Wise (aww@usp.org)
Linezolid TabletsMar. 29, 2013Authorized V.1Ahalva Wise (aww@usp.org)

Lopinavir

Aug. 28, 2009

Authorized V.1

Leonel Santos ( lxs@usp.org )

 

Lopinavir and Ritonavir Tablets

Apr. 30, 2010

Authorized V.1

Leonel Santos ( lxs@usp.org )

 

MetaxaloneAug. 30, 2013Pending Revision Cancelled. No impact on official USP–Nf monograph.Donald Min (ddm@usp.org)

 

Revision was cancelled on Nov. 20, 2015

Mifepristone

Aug. 29, 2008

Authorized V.1.1

Mary Waddell (msw@usp.org)

Mifepristone V.1

Mycophenolate Mofetil Capsules

Jun. 26,
2009

Authorized V.1

Feiwen Mao ( fm@usp.org )

 

Mycophenolate Mofetil Tablets

Jun. 26,
2009

Authorized V.1

Feiwen Mao ( fm@usp.org )

 

Nitazoxanide

Dec. 29, 2010

Authorized V.1

Leonel Santos (lxs@usp.org)

 

Olopatadine Hydrochloride

N/A

Withdrawn. Sponsor is no longer seeking FDA approval.

Feiwen Mao ( fm@usp.org )

 

Olopatadine Hydrochloride Ophthalmic Solution

N/A

Withdrawn. Sponsor is no longer seeking FDA approval.

Feiwen Mao ( fm@usp.org )

 

Oxaliplatin

Feb. 29, 2008

Authorized V.1.1

Feiwen Mao ( fm@usp.org )

Oxaliplatin V.1

Perindopril ErbumineApr. 27, 2012Authorized V.1Sujatha Ramakrishna (sxr@usp.org)

Piroctone Olamine

Feb. 29, 2008

Authorized V.1

Feiwen Mao ( fm@usp.org )

 

Risperidone Orally Disintegrating Tablets  

Apr. 30, 2010

Official in USP 35–NF 30

Ravi Ravichandran ( rr@usp.org )

 

Revision incorporated in USP–NF

Rivastigmine Tartrate Oral Solution 

Dec. 29, 2010

Authorized V.1

Elena Gonikberg ( eg@usp.org )

 

Ropivacaine 

Dec. 28, 2009

Authorized V.1

Morgan Puderbaugh (mxp@usp.org)

 

Sodium Picosulfate

Aug. 28, 2009

Published USP 37–NF 32, Second Supplement, official Dec. 1, 2015

Elena Gonikberg ( eg@usp.org )

Revision incorporated in USP–NF

Stavudine, Lamivudine, And Nevirapine Tablets  

Mar. 26, 2010

Authorized V.1

Behnam Davani ( bd@usp.org )

 

Tenofovir Disoproxil FumarateAug. 26, 2011Authorized V.1Leonel Santos (lxs@usp.org)
Tenofovir Disoproxil Fumarate TabletsAug. 26, 2011Authorized V.1Leonel Santos (lxs@usp.org)

Terbinafine Tablets

Oct. 30, 2009

Authorized V.1

Leonel Santos (lxs@usp.org)

 

Travoprost Ophthalmic Solution

Jun. 24, 2011

Authorized V.1

Feiwen Mao (fm@usp.org)

 

Voriconazole

Apr. 29, 2011

Authorized V.1

Leonel Santos (lxs@usp.org)

 

Zolmitriptan

Jun. 29,
2012

Pending Revision Cancelled. No impact on official USP–Nf monograph.Ravi Ravichandran (rr@usp.org)Revision cancelled on Nov. 20, 2015

Pending Monographs Advancing to USP–NF

The sponsors of the following Pending monographs have received full FDA approval. The Pending monographs in their entirety or specific sections are now eligible to become official USP text. The monographs listed below have either advanced to official status or are in the process of advancing to official status.

Monograph

Status

Liaison

AdapaleneOfficial December 1, 2012. This monograph was published in USP 36–NF 31.Feiwen Mao ( fm@usp.org )
Atorvastatin CalciumOfficial June 1, 2013. This monograph will be published in USP 37.Sujatha Ramakrishna ( sxr@usp.org )

Bicalutamide

Official Mar 3, 2012. This monograph was published in USP 34–NF 29, Second Supplement.

Feiwen Mao ( fm@usp.org )

CabergolineOfficial August 1, 2013. This monograph will be published in USP 37–NF 32, First Supplement.Heather Joyce (hrj@usp.org)

Carvedilol

Official May 1, 2009. This monograph was published in USP 32–NF 27, First Supplement.

Sujatha Ramakrishna ( sxr@usp.org )

Carvedilol Tablets

Official May 1, 2009. This monograph was published in USP 32–NF 27, First Supplement.

Sujatha Ramakrishna ( sxr@usp.org )

Cetirizine Hydrochloride

Official May 1, 2010. This monograph was published in USP 33–NF 28, Reissue, First Supplement

Domenick Vicchio ( dwv@usp.org )

Cetirizine Hydrochloride Oral Solution

Official May 1, 2010. This monograph was published in USP 33–NF 28, Reissue, First Supplement

Domenick Vicchio ( dwv@usp.org )

Donepezil Hydrochloride

Revision Bulletin posted April 29, 2011. Official May 1, 2011. This monograph was published in USP 35–NF 30.

Heather Joyce (hrj@usp.org)

Escitalopram Oral SolutionOfficial May 1, 2014. This monograph will be published in USP 37–NF 32.Heather Joyce (hrj@usp.org)

Famciclovir

Official February 1, 2013. This monograph was published in USP 36–31, First Supplement.Behnam Davani (bd@usp.org)
ImiquimodOfficial October 1, 2013. This monograph will be published in USP 37.Behnam Davani (bd@usp.org)

Irinotecan Hydrochloride

Official May 1, 2010. This monograph was published in USP 33–NF 28, Reissue, First Supplement

Feiwen Mao ( fm@usp.org )

Galantamine Hydrobromide

Official December 15, 2008. The revised official monograph was published in USP 32–NF 27, Second Supplement.

Heather Joyce ( hrj@usp.org )

Levetiracetam

Official May 1, 2010. This monograph was published in USP 33–NF 28, Reissue, First Supplement.

Ravi Ravichandran ( rr@usp.org )

Losartan PotassiumOfficial January 1, 2012. This monograph was published in USP 35–NF 30, Second Supplement.Sujatha Ramakrishna (sxr@usp.org)
Oxaliplatin Injection Official October 1 , 2012. This monograph was published in USP 36–NF 31, First Supplement.Feiwen Mao ( fm@usp.org )

Pantoprazole Sodium

Official June 1, 2008. This monograph was published in USP 32–NF 27.

Elena Gonikberg ( eg@usp.org )

Pantoprazole Sodium Delayed Release Tablets

Official June 1, 2008. This monograph was published in USP 32–NF 27.

Elena Gonikberg ( eg@usp.org )

Ribavirin Tablets

Official September 1, 2010. This monograph was published in USP 33–NF 28, Reissue, Second Supplement

Leonel Santos ( lxs@usp.org )

Rocuronium Bromide

Official August 1, 2009. The revised official monograph was published in USP 33–NF 28 Reissue.

Ravi Ravichandran (rr@usp.org)

TemozolomideOfficial June 1, 2013. The revised official monograph was published in USP 37–NF 32R.S. Prasad (rsp@usp.org)

Valacyclovir Hydrochloride

Official December 1, 2010. This monograph was published in USP 34–NF 29, Second Supplement.

Leonel Santos ( lxs@usp.org )

Venlafaxine Extended-Release CapsulesOfficial July 1, 2012. This monograph was published in USP 35–NF 30, Second Supplement.Ravi Ravichandran (rr@usp.org)
Ziprasidone HydrochlorideOfficial December 1, 2012. This monograph was published in USP 36–NF 31, Second Supplement.Mary P. Koleck  (mpk@usp.org)