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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 2.2
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: June 26, 2009
Next Posting Date: July 31, 2009
| Monograph |
Date Posted |
Status |
Liaison |
History |
Donepezil Hydrochloride  (148KB) |
June 26, 2009 |
Draft 2, Comment deadline is September 30, 2009 |
Hari Ramanathan () |
— |
| Ropivacaine (140KB) |
June 26, 2009 |
Draft 1, Comment deadline is September 30, 2009 |
Morgan Puderbaugh () |
— |
Draft Monographs — Previous Postings
| Monograph |
Date Posted |
Status |
Liaison |
History |
| Abacavir Tablets (107KB) |
Apr. 24, 2009 |
Draft 1, Comment deadline is July 31, 2009 |
Leonel Santos () |
— |
| Anastrozole (102KB) |
Apr. 24, 2009 |
Draft 1, Comment deadline is July 31, 2009 |
Feiwen Mao () |
— |
| Efavirenz Capsules (107KB) |
Apr. 24, 2009 |
Draft 1, Comment deadline is July 31, 2009 |
Leonel Santos () |
— |
| Efavirenz Tablets (108KB) |
Apr. 24, 2009 |
Draft 1, Comment deadline is July 31, 2009 |
Leonel Santos () |
— |
Galantamine Hydrobromide (268KB) |
Apr. 25, 2008 |
Draft 1, Comment period closed on July 31, 2008. The Draft Pending Monograph will not advance to the Authorized status. The Related compounds section of the Draft Pending Monograph was incorporated into the official USP Galantamine Hydrobromide monograph via Revision Bulletin, which was posted on the USP Web site here on November 26, 2008 with an official date of December 15, 2008. The test for Limit of 4R,8R–stereoisomer of the Draft Pending Monograph will be published as an In–process Revision in PF 35(4) [July–August 2009]. |
Ravi Ravichandran () |
— |
| Lamivudine (98KB) |
Apr. 24, 2009 |
Draft 1, Comment deadline is July 31, 2009 |
Hari Ramanathan () |
— |
Lopinavir (148KB) |
Feb. 27, 2009 |
Draft 1, Comment deadline is May 31, 2009 |
Leonel Santos () |
— |
| Risperidone Orally Disintegrating Tablets (109KB) |
May 29, 2009 |
Draft 1, Comment deadline is August 31, 2009 |
Ravi Ravichandran () |
— |
Sodium Picosulfate (265KB)
|
Sept. 28, 2007 |
Draft 1, Comment period closed on December 31, 2007. Awaiting Expert Committee approval. |
Elena Gonikberg () |
— |
| Terbinafine Tablets (107KB) |
Apr. 24, 2009 |
Draft 1, Comment deadline is July 31, 2009 |
Hari Ramanathan () |
— |
Authorized Pending Monographs — New Postings
Posting Date: June 26, 2009
Next Posting Date: July 31, 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 () |
— |
Cetirizine Hydrochloride (271KB) |
Sept. 28, 2007 |
Authorized V.1 |
Karen A. Russo () |
— |
Cetirizine Hydrochloride Oral Solution (264KB) |
Feb. 29, 2008 |
Authorized V.1 |
Karen A. Russo () |
— |
| 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) |
Efavirenz (270KB) |
Feb. 29, 2008 |
Authorized V.1 |
Behnam Davani () |
— |
Escitalopram Oxalate (278KB) |
Jun. 27, 2008 |
Authorized V.1 |
Hari Ramanathan () |
— |
| 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 (306KB) |
Aug. 29, 2008 |
Authorized V.1 |
Feiwen Mao () |
— |
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 () |
— |
Losartan Potassium (245KB) |
Aug. 29, 2008 |
Authorized V.1 |
Sujatha Ramakrishna () |
— |
Mifepristone (279KB) |
Aug. 29, 2008 |
Authorized V.1 |
Karen A. Russo () |
— |
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 (277KB) |
Feb. 29, 2008 |
Authorized V.1 |
Ravi Ravichandran () |
— |
Pending Monographs Advancing to USP–NF
The sponsors of the following monographs have received full FDA approval. In accordance with the USP previous versions of the Pending Monographs Guideline prior to April 1, 2008, these Pending Monographs are advancing toward official status in the USP–NF via publication in the Pharmacopeial Forum as proposed Interim Revision Announcements (IRA). The specific PF citation and target official date are indicated for each monograph. The current Guideline no longer requires publication in PF.
| Monograph |
Status |
Liaison |
| Carvedilol |
Official May 1, 2009. This monograph was published in USP32–NF27, 1st Supplement. |
Sujatha Ramakrishna () |
| Carvedilol Tablets |
Official May 1, 2009. This monograph was published in USP32–NF27, 1st Supplement |
Sujatha Ramakrishna () |
| Levetiracetam |
Official August 1, 2009. This monograph was published in USP 33-NF 28. |
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 () |
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