2010-2015 Work Plan
Small Molecules 4 Expert Committee
Executive Summary
August 24, 2011
Chair: Michael Cutrera, M.S.
Vice Chair: Eugene McGonigle, Ph.D.
Vice President: Karen A. Russo, Ph.D. (Small Molecules Monographs)
Director: Sanjay Sehgal, Ph.D.
Scientific Liaisons: Ravi Ravichandran, Ph.D.
Domenick Vicchio, Ph.D.
Mary "Jeanie" Waddell, B.S.
Hari Ramanathan, M.S.
Heather Joyce, Ph.D.
Project Manager: Ashley Stonehouse, B.S.
Reference Standard Scientists: Guillermo Casay, Ph.D.
Niya Yeboah, M.S.
Thelma Prensky, B.S.
Feng Zhao, Ph.D.
Expert Committee Charge:
Small Molecules 4 is responsible for the development and revision of USP-NF and Pending monographs and their
associated USP Reference Standards in the following therapeutic categories: Psychoactives, Psychiatrics, Pulmonary,
Steroids, Aerosols and Radiopharmaceuticals.
Progress
Starting Point
as of
1-Jul-10 August 2011
Official Monographs 1192 1204
Missing Monographs 390 355
Official Monographs Needing
234 216
Modernization
Official Reference Standards 621 677
2010-2011 Small Molecules 4 Initiative(s)
Work with Small Molecules Expert Committees, FDA and stakeholders to improve
existing OTC monographs and develop new OTC product monographs
Small Molecules 4 Subcommittees
Subcommittee A (Psychoactives and Psychiatrics A-H and Radiopharmaceuticals)
Subcommittee B (Pulmonary and Steroids I-Z and Aerosols)
2010-2015 Work
Subcommittee C (Psychoactives and Psychiatrics I-Z) Plan
Small Molecules 4 Expert Committee
Executive Summary
August 24, 2011
Page 1 of 9
Subcommittee D (Pulmonary and Steroids A-H)
Potential Small Molecules 4 Expert Panel(s)
Radiopharmaceuticals
Aerosols
2010-2015 Work Plan
Small Molecules 4 Expert Committee
Executive Summary
August 24, 2011
Page 2 of 9
2010-2015 Work Plan
Small Molecules 4 Expert Committee
August 24, 2011
The following new and revised monographs are in development. The target Pharmacopeial Forum (PF) publication or web posting date (for Revision Bulletins or Pending
Monographs) is indicated if known. Progress on other activities is indicated, as appropriate. Several of the monographs may have a status of "On Hold" or "Waiting on RS". A
monograph with a status of "On Hold" is typically waiting for a revised method, a data package or FDA approval. A status of "Waiting for RS" means that the draft monograph is
complete, but is waiting on the reference standard to arrive in-house before moving forward. Also included is a list of new USP Reference Standards (RS) in development.
Target Forum or Posting Date
Monograph Scientific Liaison Comments
(if known)
New USP Monographs in Development
1 ALBUTEROL EXTENDED-RELEASE TABLETS Domenick Vicchio
2
ARIPIPRAZOLE Hariram Ramanathan
3 ATOMOXETINE CAPSULES Hariram Ramanathan
4 ATOMOXETINE HYDROCHLORIDE Hariram Ramanathan On Hold
5 AZELASTINE HYDROCHLORIDE Heather R. Joyce
6
CARBON MONOXIDE O 15 Ravi Ravichandran On Hold
7 DESLORATADINE Domenick Vicchio Waiting for RS
8
DESLORATADINE ORALLY DISINTEGRATING TABLETS Domenick Vicchio
9 DUTASTERIDE Domenick Vicchio
10 EPOPROSTENOL FOR INJECTION Domenick Vicchio
11 FLUORODEOXYTHYMIDINE F 18 INJECTION Ravi Ravichandran On hold
12 FLUTICASONE PROPIONATE AND SALMETEROL
XINAFOATE INHALATION AEROSOL Ravi Ravichandran
13 FLUTICASONE PROPIONATE AND SALMETEROL
XINAFOATE INHALATION POWDER Ravi Ravichandran
14
FLUTICASONE PROPIONATE INHALATION AEROSOL Ravi Ravichandran
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2010-2015 Work Plan
Small Molecules 4 Expert Committee
August 24, 2011
15
FLUTICASONE PROPIONATE INHALATION POWDER Ravi Ravichandran
16
GLYCINE AND SODIUM CHLORIDE INJECTION Domenick Vicchio
17
LEVOCETIRIZINE DIHYDROCHLORIDE Mary S. Waddell
18
LEVOCETIRIZINE DIHYDROCHLORIDE TABLETS Mary S. Waddell
19
LORATADINE CHEWABLE TABLETS Mary S. Waddell
20
MANNITOL INHALATION POWDER Ravi Ravichandran On Hold
21 MEMANTINE HYDROCHLORIDE Hariram Ramanathan On Hold
22 MEMANTINE HYDROCHLORIDE TABLETS Hariram Ramanathan
23 NITRIC OXIDE Ravi Ravichandran On Hold
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE
24
TABLETS Hariram Ramanathan On Hold
25 OXYGEN O 15 Ravi Ravichandran
26 PAROXETINE EXTENDED-RELEASE TABLETS Hariram Ramanathan On Hold
27 PRAMIPEXOLE DIHYDROCHLORIDE TABLETS Hariram Ramanathan
28 RUFINAMIDE 37(6) [Nov.-Dec.2011] Hariram Ramanathan
29 RUFINAMIDE TABLETS 37(6) [Nov.-Dec.2011] Hariram Ramanathan
30
SALMETEROL XINAFOATE INHALATION POWDER Ravi Ravichandran
31 SERTRALINE ORAL SOLUTION 37(5) [Sep.-Oct. 2011] Hariram Ramanathan On Hold
32 SUMATRIPTAN INJECTION 37(5) [Sep.-Oct. 2011] Ravi Ravichandran
33
TADALAFIL 38 (1) [Jan. - Feb. 2012] Mary S. Waddell
34 TADALAFIL TABLETS 38 (1) [Jan. - Feb. 2012] Mary S. Waddell
35 THEOPHYLLINE EXTENDED_RELEASE TABLETS Mary S. Waddell
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2010-2015 Work Plan
Small Molecules 4 Expert Committee
August 24, 2011
36 TRIAMCINOLONE ACETONIDE NASAL SPRAY Domenick Vicchio
37 VECURONIUM BROMIDE FOR INJECTION Hariram Ramanathan On Hold
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE
38
CAPSULES Hariram Ramanathan
39 VIGABATRIN Heather R. Joyce
40 ZAFIRLUKAST Mary S. Waddell
41 ZAFIRLUKAST TABLETS Mary S. Waddell
New Pending Monographs in Development
1 ARIPIPRAZOLE Hariram Ramanathan On Hold
2 BUPROPION HYDROBROMIDE Heather R. Joyce
3 DUTASTERIDE Domenick Vicchio
4 EPINASTINE HYDROCHLORIDE Domenick Vicchio
5 ESCITALOPRAM ORAL SOLUTION Hariram Ramanathan On Hold
6 METAXALONE Hariram Ramanathan On Hold
7 PALIPERIDONE Hariram Ramanathan
8 QUETIAPINE TABLETS Hariram Ramanathan
USP Monograph Modernizations in Development
1 ATROPINE SULFATE Heather R. Joyce
2 BACLOFEN Heather R. Joyce
3 BROMPHENIRAMINE MALEATE Morgan Puderbaugh On Hold
4 BUTABARBITAL SODIUM ORAL SOLUTION Ravi Ravichandran
5 BUTALBITAL Heather R. Joyce
6 CHLORPHENIRAMINE MALEATE Domenick Vicchio On Hold
7 CLEMASTINE FUMARATE Domenick Vicchio
8 CLEMASTINE FUMARATE TABLETS Domenick Vicchio
9 CYCLOBENZAPRINE HYDROCHLORIDE Ravi Ravichandran
10 DESIPRAMINE HYDROCHLORIDE Hariram Ramanathan On Hold
11 DESIPRAMINE HYDROCHLORIDE TABLETS Hariram Ramanathan On Hold
12 DEXCHLORPHENIRAMINE MALEATE Domenick Vicchio On Hold
13 DICHLORALPHENAZONE Ravi Ravichandran
14
DYPHYLLINE AND GUAIFENESIN ORAL SOLUTION Morgan Puderbaugh On Hold
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2010-2015 Work Plan
Small Molecules 4 Expert Committee
August 24, 2011
15 DYPHYLLINE ORAL SOLUTION Morgan Puderbaugh On Hold
16 EPINEPHRINE Domenick Vicchio On Hold
17 HALOPERIDOL 37(6) [Nov.-Dec 2011] Hariram Ramanathan Waiting for RS
18 LIDOCAINE HCl JELLY Mary Waddell
19 LIDOCAINE OINTMENT Mary Waddell
20 MEPIVACAINE HYDROCHLORIDE Mary Waddell
21 MEPROBAMATE Hariram Ramanathan On Hold
22 MESORIDAZINE BESYLATE Hariram Ramanathan
23 NORTRIPTYLINE HYDROCHLORIDE Hariram Ramanathan
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE
24
TABLETS Hariram Ramanathan On Hold
25 OXAZEPAM Hariram Ramanathan
26 PHENYTOIN SODIUM INJECTION Hariram Ramanathan On Hold
27 SECOBARBITAL SODIUM CAPSULES Heather R. Joyce
28 THIORIDAZINE HYDROCHLORIDE Hariram Ramanathan
29 TRAZODONE HYDROCHLORIDE Hariram Ramanathan
30 VALPROATE SODIUM INJECTION Hariram Ramanathan
28 VALPROIC ACID Heather R. Joyce
29 VALPROIC ACID CAPSULES Heather R. Joyce
30 VALPROIC ACID ORAL SOLUTION Heather R. Joyce
USP Monograph Revisions in Development
1 ALCLOMETASONE DIPROPIONATE Domenick Vicchio On Hold
ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE
2
TABLETS Domenick Vicchio On Hold
3 ALPRAZOLAM TABLETS Ravi Ravichandran
4 AMLEXANOX Ravi Ravichandran On Hold
5 AMMONIA N 13 INJECTION Ravi Ravichandran
6 AMOXAPINE TABLETS Ravi Ravichandran
7 BUDESONIDE Domenick Vicchio On Hold
8 CALCIUM ACETATE Domenick Vicchio
CARBIDOPA AND LEVODOPA EXTENDED-RELEASE
9
TABLETS Heather R. Joyce
10 CARBIDOPA AND LEVODOPA TABLETS Ravi Ravichandran On Hold
11 CARBOPROST TROMETHAMINE Domenick Vicchio On Hold
12 CETIRIZINE HYDROCHLORIDE Domenick Vicchio
13 CETIRIZINE HYDROCHLORIDE TABLETS Domenick Vicchio
14 CONJUGATED ESTROGENS TABLETS Domenick Vicchio
15 DANTROLENE SODIUM Ravi Ravichandran
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2010-2015 Work Plan
Small Molecules 4 Expert Committee
August 24, 2011
16 DEXAMETHASONE ORAL SOLUTION Domenick Vicchio On Hold
17 DEXAMETHASONE SODIUM PHOSPHATE 37(6) [Nov.-Dec 2011] Domenick Vicchio
18 DINOPROSTONE Domenick Vicchio
19 DONEPEZIL HYDROCHLORIDE Ravi Ravichandran
20 DULOXETINE HYDROCHLORIDE Ravi Ravichandran
21 EPINEPHRINE BITARTRATE Domenick Vicchio On Hold
22 ESTAZOLAM Hariram Ramanathan
23
ESTRADIOL AND NORETHINDRONE ACETATE TABLETS Domenick Vicchio
24 ETHINYL ESTRADIOL TABLETS Domenick Vicchio On Hold
FEXOFENADINE HYDROCHLORIDE AND
25 PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-
RELEASE TABLETS Domenick Vicchio On Hold
26 GADOPENTETATE DIMEGLUMINE INJECTION Ravi Ravichandran
27 GALANTAMINE HYDROBROMIDE 37(6) Nov Dec 2011 Ravi Ravichandran
28 GALANTAMINE TABLETS Ravi Ravichandran On Hold
29 IODIXANOL Ravi Ravichandran
30 IOHEXOL Ravi Ravichandran
31 ISOMETHEPTENE MUCATE Ravi Ravichandran
32 LAMOTRIGINE TABLETS FOR ORAL SUSPENSION Ravi Ravichandran
33 LEVALBUTEROL HYDROCHLORIDE 37(6) [Nov.-Dec 2011] Ravi Ravichandran
34 LEVALBUTEROL INHALATION SOLUTION 37(6) Nov-Dec 2011 Ravi Ravichandran
35 LEVETIRACETAM TABLETS Hariram Ramanathan
36 LEVODOPA Hariram Ramanathan
37 LEVODOPA CAPSULES Hariram Ramanathan
38 LEVODOPA TABLETS Hariram Ramanathan
39 LITHIUM ORAL SOLUTION Hariram Ramanathan
LORATADINE AND PSEUDOEPHEDRINE SULFATE
40
EXTENDED-RELEASE TABLETS Mary S. Waddell On Hold
41 LORATADINE TABLETS Mary S. Waddell
42 LORAZEPAM ORAL CONCENTRATE Hariram Ramanathan
43 MEPROBAMATE TABLETS Hariram Ramanathan On Hold
44 MIDAZOLAM Mary S. Waddell
45 MIRTAZAPINE 37(6) Nov-Dec 2011 Ravi Ravichandran
46 MIRTAZAPINE TABLETS 37(6) Nov Dec 2011 Ravi Ravichandran
47 MODAFINIL Mary S. Waddell On Hold
48 MODAFINIL TABLETS Mary S. Waddell On Hold
49
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS Mary S. Waddell
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2010-2015 Work Plan
Small Molecules 4 Expert Committee
August 24, 2011
50 OLANZAPINE Hariram Ramanathan
51
ONDANSETRON ORALLY DISINTEGRATING TABLETS Mary S. Waddell On Hold
52 OXANDROLONE Mary S. Waddell On Hold
53 OXAZEPAM CAPSULES Hariram Ramanathan
54 OXCARBAZEPINE Hariram Ramanathan On Hold
55 OXCARBAZEPINE TABLETS Hariram Ramanathan
56 OXYGEN Ravi Ravichandran On Hold
57 PANCURONIUM BROMIDE Ravi Ravichandran
58 PRAMIPEXOLE DIHYDROCHLORIDE TABLETS Hariram Ramanathan
59 PRIMIDONE TABLETS Hariram Ramanathan
60 PROMETHAZINE HYDROCHLORIDE Mary S. Waddell
61 PROMETHAZINE HYDROCHLORIDE TABLETS Mary S. Waddell
62 RALOXIFENE HYDROCHLORIDE 37(6) [Nov.-Dec 2011] Mary S. Waddell
63 RALOXIFENE HYDROCHLORIDE TABLETS 37(6) [Nov.-Dec 2011] Mary S. Waddell
64 RISPERIDONE Heather R. Joyce
65 RISPERIDONE ORAL SOLUTION Hariram Ramanathan
66
RISPERIDONE ORALLY DISINTEGRATING TABLETS Hariram Ramanathan
67 ROPINIROLE HYDROCHLORIDE Ravi Ravichandran
68 SERTRALINE HYDROCHLORIDE Hariram Ramanathan
69 SUMATRIPTAN TABLETS Hariram Ramanathan
70 TEMAZEPAM Hariram Ramanathan
71 TESTOSTERONE Mary S. Waddell
72 THIORIDAZINE HYDROCHLORIDE TABLETS Hariram Ramanathan
73 TIZANIDINE TABLETS Hariram Ramanathan
74 TOPIRAMATE CAPSULES Hariram Ramanathan
75 ZIPRASIDONE HYDROCHLORIDE Hariram Ramanathan
76 ZOLPIDEM TARTRATE TABLETS Hariram Ramanathan
Pending Monograph Revisions in Development
1 ALMOTRIPTAN MALATE Ravi Ravichandran
2 ATOMOXETINE HYDROCHLORIDE Hariram Ramanathan
3 ESZOPICLONE Ravi Ravichandran
4 ZIPRASIDONE HYDROCHLORIDE Hariram Ramanathan
5 ZOLMITRIPTAN Hariram Ramanathan
Page 8 of 9
2010-2015 Work Plan
Small Molecules 4 Expert Committee
August 24, 2011
Other Topics and Activities Milestone/Deliverable
RADIOPHARMACEUTICALS FOR POSITRON Physical Analysis EC is responsible for the major revision of this General Chapter. Changes are being made in order to align
1
EMISSION TOMOGRAPHY--COMPOUNDING with the cGMP final rule for PET drugs by the FDA.
New USP Reference Standards in Development
Monograph Name Publication Type USP RS Name
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