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 create a Pending Monograph as authorized text. Once FDA approval is granted, USP then works with the sponsor to move that monograph 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 2.7 (effective November 1, 2011).

As new and revised Pending Monographs become available, they are posted on the USP website on a monthly basis on the last Friday of each month. Monographs posted in draft for comment include the deadline for submitting comments and the email address of the USP staff person to whom comments should be directed. Following review of comments and approval by the relevant Expert Committee, the Authorized Pending Standard is posted to this website.

For additional information, contact Shawn Dressman, Ph.D. (sfd@usp.org)

Draft Monographs — No New Postings

Posting Date: April 26, 2013

Monograph

Date Posted

Status

Liaison

History

Acamprosate CalciumApr. 26, 2013Draft 1, comment period ends Jul. 31, 2013.Heather Joyce (hrj@usp.org)   
    —
DalfampridineApr. 26, 2013Draft 1, comment period ends Jul. 31, 2013.Heather Joyce (hrj@usp.org)    —
EtonogestrelApr. 26, 2013Draft 1, comment period ends Jul. 31, 2013.Domenick Vicchio (dwv@usp.org)    —

Next Posting Date: May 31, 2013

Draft Monographs — Previous Postings

Monograph

Date Posted

Status

Liaison

History

AripiprazoleJan. 27, 2012Draft 1, comment period ended Apr. 30, 2012. Awaiting Expert Committee approval.Heather Joyce (hrj@usp.org)
—
Colesevelam HydrochlorideAug. 31, 2012Draft 1, comment period ended Nov. 30, 2012. Awaiting Expert Committee approval.Sujatha Ramakrishna (sxr@usp.org)—
Escitalopram Oral SolutionAug. 26, 2011Draft 1, comment period ended Nov. 30, 2011. Awaiting Expert Committee approval.Heather Joyce (hrj@usp.org)—

Ibandronate Sodium

Nov. 24, 2010

Draft 1, comment period ended Feb. 28, 2011. Awaiting Expert Committee approval.

Elena Gonikberg (eg@usp.org)

 

—

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)—
MetaxaloneDec. 28, 2012Draft 1, comment period ends March 31, 2013.Donald Min (ddm@usp.org)—
PaliperidoneMay 25, 2012Draft 1, comment period ended Aug. 31, 2012. Awaiting Expert Committee approval.Ravi Ravichandran (rr@usp.org)

 

          —

Rabeprazole SodiumFeb. 22, 2013Draft 1, comment period ends May 31, 2013.Elena Gonikberg (eg@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, 2011Draft 1, comment period ended Mar. 31, 2012. Awaiting Expert Committee approval.Ravi Ravichandran (rr@usp.org)—

Zoledronic Acid

Aug. 27, 2010

Draft 1, comment period ended Nov. 30, 2010. Awaiting Expert Committee approval.

Elena Gonikberg (eg@usp.org)

 

—

Authorized Pending Monographs — New Postings

Posting Date: April 26, 2013

Monograph

Date Posted

Status

Liaison

History

Bupropion HydrbromideApr. 26, 2013Authorized V.1Heather Joyce (hrj@usp.org)         —
CabergolineApr. 26, 2013Authorized V.1Heather Joyce (hrj@usp.org)         —
Eprosartan MesylateApr. 26, 2013Authorized V.1Sujatha Ramakrishna (sxr@usp.org)         —

Next Posting Date: May 31, 2013

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)

—

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, 2012Authorized V.1Heather Joyce (hrj@usp.org)—
Aprepitant

Jun. 29,
2012

Authorized V.1Elena Gonikberg (eg@usp.org)—
Atomoxetine HydrochlorideDec. 28, 2011Authorized V.1Heather Joyce (hrj@usp.org)—
Atorvastatin CalciumFeb. 24, 2012Authorized V.1Elena Gonikberg (eg@usp.org)         —
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

Bicalutamide

N/A

See Pending Monographs Advancing to USP–NF section below.

Feiwen Mao (fm@usp.org)

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

         —         

Cefditoren Pivoxil

Jun. 26,
2009

Authorized V.1

Ahalya Wise (aww@usp.org)

 

—
ClimbazoleOct. 28, 2011Authorized V.1Feiwen Mao (fm@usp.org)—
Didanosine Tablets for Oral SuspensionFeb. 24, 2012Authorized V.1Behnam Davani (bd@usp)

   

         —

Donepezil Hydrochloride

NA

See Pending Monographs Advancing to USP–NF section below.

Heather Joyce (hrj@usp.org)

Donepezil Hydrochloride V.2

Donepezil Hydrochloride Tablets

Feb. 29, 2008

Authorized V.2

Heather Joyce (hrj@usp.org)

Donepezil Hydrochloride Tablets V.1

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

Leonel Santos (lxs@usp.org)

 

—

Emtricitabine Capsules

Dec. 29, 2010

Authorized V.1

Leonel Santos (lxs@usp.org)

 

—

Escitalopram Tablets 

May 29, 2009

Authorized V.1

Heather Joyce (hrj@usp.org)

 

—
Escitalopram Oral SolutionApr. 27, 2012Authorized V.1Heather Joyce (hrj@usp.org)—

Escitalopram Oxalate 

Apr. 30, 2010

Authorized V.2

Heather Joyce (hrj@usp.org)

Escitalopram Oxalate V.1.1

Esomeprazole Magnesium   

Dec. 29, 2010

Authorized V.1

Elena Gonikberg (eg@usp.org)

 

—
EszopicloneSep. 30, 2011Authorized V.1

Heather Joyce (hrj@usp.org)

—

Ethylhexyl Triazone

Feb. 29, 2008

Authorized V.1

Feiwen Mao (fm@usp.org)

—

Exemestane

Dec. 29, 2010

Authorized V.1

Feiwen Mao (fm@usp.org)

 

—

Famciclovir

Apr. 30, 2010

Authorized V.1

Behnam Davani (bd@usp.org)

 

—

Famciclovir Tablets

Apr. 30, 2010

Authorized V.1

Behnam Davani (bd@usp.org)

 

—

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)

 

—

Imiquimod

Apr. 29, 2011

Authorized V.1

Behnam Davani (bd@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

Authorized V.1

Ravi Ravichandran (rr@usp.org)

 

—

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)         —

Losartan Potassium

N/A

See Pending Monographs Advancing to USP–NF section below.

Sujatha Ramakrishna (sxr@usp.org)

Losartan Potassium V.1

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)

 

—

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

Oxaliplatin Injection  

Apr. 29, 2011

Authorized V.1

Feiwen Mao (fm@usp.org)

 

—
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

Authorized V.1

Ravi Ravichandran (rr@usp.org)

 

—

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

Authorized V.1

Elena Gonikberg (eg@usp.org)

 

—

Stavudine, Lamivudine, And Nevirapine Tablets  

Mar. 26, 2010

Authorized V.1

Behnam Davani (bd@usp.org)

 

—

Temozolomide

Apr. 30, 2010

Authorized V.1

Feiwen Mao (fm@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

June 24, 2011

Authorized V.1

Feiwen Mao (fm@usp.org)

 

—

Venlafaxine Extended-Release Capsules

N/A

See Pending Monographs Advancing to USP–NF section below.

Ravi Ravichandran (rr@usp.org)

Venlafaxine Extended-Release Capsules V.1

Voriconazole 

Apr. 29, 2011

Authorized V.1

Leonel Santos (lxs@usp.org)

 

—
Zolmitriptan

Jun. 29,
2012

Authorized V.1Ravi Ravichandran (rr@usp.org)—

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 USP36–NF31. Feiwen Mao (fm@usp.org)

Bicalutamide

Sponsor obtained FDA approval. The organic impurities (chromatographic purity) and assay procedures of the Authorized V.1 Pending monograph have been proposed as a revision to the official USP Bicalutamide monograph and appeared in PF 36(5) for public comment. The remaining FDA approved procedures are consistent with the current official monograph.

Feiwen Mao (fm@usp.org)

Carvedilol

Official May 1, 2009. This monograph was published in USP32–NF27, First Supplement.

Sujatha Ramakrishna (sxr@usp.org)

Carvedilol Tablets

Official May 1, 2009. This monograph was published in USP32–NF27, First Supplement.

Sujatha Ramakrishna (sxr@usp.org)

Cetirizine Hydrochloride

Official May 1, 2010. This monograph was published in USP33–NF28, Reissue, First Supplement

Domenick Vicchio (dwv@usp.org)

Cetirizine Hydrochloride Oral Solution

Official May 1, 2010. This monograph was published in USP33–NF28, 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 USP35–NF30.

Heather Joyce (hrj@usp.org)

Irinotecan Hydrochloride

Official May 1, 2010. This monograph was published in USP33–NF28, Reissue, First Supplement

Feiwen Mao (fm@usp.org)

Galantamine Hydrobromide

Official December 15, 2008. The revised official monograph was published in USP32–NF27, Second Supplement.

Heather Joyce (hrj@usp.org)

Levetiracetam

Official May 1, 2010. This monograph was published in USP33–NF28, Reissue, First Supplement.

Ravi Ravichandran (rr@usp.org)

Losartan PotassiumOfficial January 1, 2012. This monograph was published in USP35–NF30, Second Supplement.Sujatha Ramakrishna (sxr@usp.org)

Pantoprazole Sodium

Official June 1, 2008. This monograph was published in USP32–NF27.

Elena Gonikberg (eg@usp.org)

Pantoprazole Sodium Delayed Release Tablets

Official June 1, 2008. This monograph was published in USP32–NF27.

Elena Gonikberg (eg@usp.org)

Ribavirin Tablets

Official September 1, 2010. This monograph was published in USP33–NF28, Reissue, Second Supplement

Leonel Santos (lxs@usp.org)

Rocuronium Bromide

Official August 1, 2009. The revised official monograph was published in USP33–NF28 Reissue.

Ravi Ravichandran (rr@usp.org)

Valacyclovir Hydrochloride

Official December 1, 2010. This monograph was published in USP34–NF29, Second Supplement.

Leonel Santos (lxs@usp.org)

Venlafaxine Extended-Release CapsulesOfficial July 1, 2012. This monograph was published in USP35–NF30, Second Supplement. Ravi Ravichandran (rr@usp.org)