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Information For:
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USP Pending Monographs
USP provides Pending Monographs for certain drug products and their drug substances 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 2.4
As new and revised Pending Monographs become available, they will be posted on the USP Web site on a monthly basis on the last Friday of each month. Monographs posted in draft for comment will also indicate the deadline for submitting comments and the e–mail 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 will be posted to this Web site.
For additional information, contact Karen A. Russo, Ph.D., ()
Draft Monographs — New Postings
Posting Date: October 30, 2009
Next Posting Date: November 30, 2009
| Monograph
| Date Posted
| Status
| Liaison
| History
|
Gatifloxacin  (135KB) |
Oct. 30, 2009 |
Draft 2, Comment deadline is Jan. 31, 2010 |
Hari Ramanathan () |
— |
| Iron Sucrose Injection (103KB) |
Oct. 30, 2009 |
Draft 1, Comment deadline is Jan. 31, 2010 |
Sujatha Ramakrishna () |
— |
| Temozolomide (121KB) |
Oct. 30, 2009 |
Draft 1, Comment deadline is Jan. 31, 2010 |
Feiwen Mao () |
— |
Draft Monographs — Previous Postings
| Monograph
| Date Posted
| Status
| Liaison
| History
|
| Abacavir Sulfate (155KB) |
Aug. 28, 2009 |
Draft 2, Comment deadline is Nov. 30, 2009 |
Leonel Santos () |
— |
| Donepezil Hydrochloride (148KB) |
June 26, 2009 |
Draft 2, Comment deadline is Sept. 30, 2009 |
Hari Ramanathan () |
— |
| Esomeprazole Magnesium (129KB) |
Sept. 25, 2009 |
Draft 1, Comment deadline is Dec. 31, 2009 |
Elena Gonikberg () |
— |
Galantamine Hydrobromide |
N/A |
See Pending Monographs Advancing to USP—NF section below |
Ravi Ravichandran () |
Galantamine Hydrobromide V.1 (89KB) |
| Lamivudine Oral Solution (98KB) |
Sept. 25, 2009 |
Draft 1, Comment deadline is Dec. 31, 2009 |
Hari Ramanathan () |
— |
| Lamivudine, Zidovudine, And Nevirapine Tablets (126KB) |
Aug. 28, 2009 |
Draft 1, Comment deadline is Nov. 30, 2009 |
Behnam Davani () |
— |
| Ribavarin Tablets (122KB) |
July 31, 2009 |
Draft 1, Comment deadline is Oct. 31, 2009 |
Leonel Santos () |
— |
| Risperidone Orally Disintegrating Tablets (109KB) |
May 29, 2009 |
Draft 1, Comment period closed on July 31, 2009. Awaiting Expert Committee approval. |
Ravi Ravichandran () |
— |
| Ropivacaine (140KB) |
June 26, 2009 |
Draft 1, Comment deadline is Sept. 30, 2009 |
Morgan Puderbaugh () |
— |
| Stavudine, Lamivudine, And Nevirapine Tablets (125KB) |
Aug. 28, 2009 |
Draft 1, Comment deadline is Nov. 30, 2009 |
Behnam Davani () |
— |
| Venlafaxine Extended—Release Capsules (120KB) |
Aug. 28, 2009 |
Draft 1, Comment deadline is Nov. 30, 2009 |
Hari Ramanathan () |
— |
Authorized Pending Monographs — New Postings
Posting Date: October 30, 2009
| Monograph
| Date Posted
| Status
| Liaison
| History
|
Abacavir Tablets (88KB) |
Oct. 30, 2009 |
Authorized V.1 |
Leonel Santos () |
— |
Anastrozole (82KB) |
Oct. 30, 2009 |
Authorized V.1 |
Feiwen Mao () |
— |
Efavirenz Capsules (87KB) |
Oct. 30, 2009 |
Authorized V.1 |
Leonel Santos () |
— |
Efavirenz Tablets (88KB) |
Oct. 30, 2009 |
Authorized V.1 |
Leonel Santos () |
— |
Lamivudine (76KB) |
Oct. 30, 2009 |
Authorized V.1 |
Hari Ramanathan () |
— |
Terbinafine Tablets (88KB)
|
Oct. 30, 2009 |
Authorized V.1 |
Hari Ramanathan () |
— |
Next Posting Date: November 30, 2009
Authorized Pending Monographs — Previous Postings
| Monograph
| Date Posted
| Status
| Liaison
| History
|
Abacavir Oral Solution (267KB) |
Feb. 29, 2008 |
Authorized V.1 |
Behnam Davani () |
— |
Abacavir Sulfate (272KB) |
Feb. 29, 2008 |
Authorized V.1 |
Behnam Davani () |
— |
Bemotrizinol (90KB) |
Jan. 30, 2009 |
Authorized V.2 |
Feiwen Mao () |
Bemotrizinol V.1 (280KB) |
Bicalutamide (474KB) |
Feb. 29, 2008 |
Authorized V.1 |
Feiwen Mao () |
— |
| Cefditoren Pivoxil (146KB) |
June 26, 2009 |
Authorized V.1 |
Ahalya Wise (
) |
— |
Cetirizine Hydrochloride |
N/A |
See Pending Monographs Advancing to USP—NF section below |
Domenick Vicchio () |
Cetirizine Hydrochloride, V .1 (88KB) |
Cetirizine Hydrochloride Oral Solution |
N/A |
See Pending Monographs Advancing to USP—NF section below |
Domenick Vicchio () |
Cetirizine Hydrochloride Oral Solution, V .1 (85KB) |
| Donepezil Hydrochloride (270KB) |
Feb. 29, 2008 |
Authorized V.1 |
Ravi Ravichandran () |
— |
Donepezil Hydrochloride Tablets (211KB) |
Feb. 27, 2008 |
Authorized V.2 |
Ravi Ravichandran () |
Donepezil Hydrochloride Tablets V.1 (270KB) |
| Escitalopram Oxalate (93KB) |
July 31, 2009 |
Authorized V.1.1 |
Hari Ramanathan () |
Escitalopram Oxalate V.1 (100KB) |
Efavirenz (270KB) |
Feb. 29, 2008 |
Authorized V.1 |
Behnam Davani () |
— |
| Escitalopram Tablets (86KB) |
May 29, 2009 |
Authorized V.1 |
Hari Ramanathan (
) |
— |
Ethylhexyl Triazone (294KB) |
Feb. 29, 2008 |
Authorized V.1 |
Feiwen Mao () |
— |
Gatifloxacin (275KB) |
Jun. 27, 2008 |
Authorized V.1 |
Behnam Davani () |
— |
Irinotecan Hydrochloride |
N/A |
See Pending Monographs Advancing to USP—NF section below |
Feiwen Mao () |
Irinotecan Hydrochloride V .1 (306KB) |
Levofloxacin (92KB) |
Jan. 30, 2009 |
Authorized V.2 |
Morgan Puderbaugh () |
Levofloxacin V.1 (281KB) |
Lamivudine Tablets (265KB) |
Aug. 29, 2008 |
Authorized V.1 |
Hari Ramanathan () |
— |
Lamotrigine (505KB) |
Nov. 23, 2007 |
Authorized V.1 |
Ravi Ravichandran () |
— |
Levetiracetam |
N/A |
See Pending Monographs Advancing to USP—NF section below |
Ravi Ravichandran () |
Levetiracetam V.1 (101KB) |
Losartan Potassium (245KB) |
Aug. 29, 2008 |
Authorized V.1 |
Sujatha Ramakrishna () |
— |
Lopinavir (141KB) |
Aug. 28, 2009 |
Authorized V.1 |
Leonel Santos () |
— |
Mifepristone (279KB) |
Aug. 29, 2008 |
Authorized V.1 |
Karen A. Russo () |
— |
Mycophenolate Mofetil Capsules (100KB) |
June 26, 2009 |
Authorized V.1 |
Feiwen Mao () |
— |
Mycophenolate Mofetil Tablets (101KB) |
June 26, 2009 |
Authorized V.1 |
Feiwen Mao () |
— |
Olopatadine Hydrochloride (272KB) |
Feb. 29, 2008 |
Authorized V.1 |
Feiwen Mao () |
— |
Olopatadine Hydrochloride Ophthalmic Solution (449KB) |
Feb. 29, 2008 |
Authorized V.1 |
Feiwen Mao () |
— |
Oxaliplatin (526KB) |
Feb. 29, 2008 |
Authorized V.1 |
Feiwen Mao () |
— |
Piroctone Olamine (272KB) |
Feb. 29, 2008 |
Authorized V.1 |
Feiwen Mao () |
— |
Rocuronium Bromide |
N/A |
See Pending Monographs Advancing to USP—NF section below |
Ravi Ravichandran () |
Rocuronium Bromide V.1 (102KB) |
Sodium Picosulfate (130KB)
|
Aug. 28, 2009 |
Authorized V.1 |
Elena Gonikberg () |
— |
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
|
| Carvedilol |
Official May 1, 2009. This monograph was published in USP32–NF27, First Supplement. |
Sujatha Ramakrishna () |
| Carvedilol Tablets |
Official May 1, 2009. This monograph was published in USP32–NF27, First Supplement. |
Sujatha Ramakrishna () |
| Cetirizine Hydrochloride |
Revision Bulletin posted on October 30, 2009. Official May 1, 2010. This monograph will be published in USP33–NF28, First Supplement |
Domenick Vicchio () |
| Cetirizine Hydrochloride Oral Solution |
Revision Bulletin posted on October 30, 2009. Official May 1, 2010. This monograph will be published in USP33–NF28, First Supplement |
Domenick Vicchio () |
| Irinotecan Hydrochloride |
Revision Bulletin posted on October 30, 2009. Official May 1, 2010. This monograph will be published in USP33–NF28, First Supplement |
Feiwen Mao () |
| Galantamine Hydrobromide |
Revision Bulletin posted on November 26, 2008. The Related compounds section of the Draft Pending Monograph was incorporated into the official USP Galantamine Hydrobromide monograph via Revision Bulletin with an official date of December 15, 2008. The revised monograph was published in USP32—NF27, Second Supplement. The test for Limit of 4R,8R—stereoisomer of the Draft Pending Monograph will be published as an In—process Revision in an future issue of PF. |
Ravi Ravichandran () |
| Levetiracetam |
Revision Bulletin posted on June 26, 2009. Official August 1, 2009. An updated Revision Bulletin Notice was posted on August 18, 2009 to clarify information in the Notice only and there were no changes to the monograph content. This official monograph will be published in USP33—NF28, First Supplement. |
Ravi Ravichandran () |
| Pantoprazole Sodium |
Official June 1, 2008. This monograph was published in USP32–NF27. |
Elena Gonikberg () |
| Pantoprazole Sodium Delayed Release Tablets |
Official June 1, 2008. This monograph was published in USP32–NF27. |
Elena Gonikberg () |
| Rocuronium Bromide |
Revision Bulletin posted
on March 27, 2009. Official August 1, 2009. Sections of the Authorized Pending Monograph were incorporated into the official USP monograph. The revised official monograph will be published in USP33—NF28. |
Ravi Ravichandran () |
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