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USP Guideline on Standards for Articles Legally Marketed Outside the U.S.
Background
The United States Pharmacopeia (USP) approach for Standards for Articles Legally
Marketed Outside the U.S. (SALMOUS) allows the creation of documentary standards
(monographs) for drug substances and drug products that have been approved
in and are legally marketed in countries other than the U.S. and are intended
to treat neglected diseases, as listed in the Attachment. Where appropriate,
USP will provide physical reference standards to support testing of an article
against a SALMOUS monograph.
Requirements
In order for monographs for a drug product and/or its drug substance to be
developed under the SALMOUS approach, the Sponsor must:
- Not have obtained final approval from the Food and Drug Administration (FDA) of the drug product and/or its drug substance in the U.S.
- Have obtained approval for the drug product and/or its drug substance in a country with a stringent regulatory authority (which shall include those countries listed in Section 802 of the Federal Food, Drug and Cosmetic Act as well as those identified on The Global Fund list found at http://www.theglobalfund.org/pdf/guidelines/List_of_Countries_ICH_PICS.pdf, which includes those countries participating in the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme and the International Conference on Harmonisation). This requirement may be met through tentative approval of the drug product by FDA, such as tentative approval granted under the President's Emergency Plan for AIDS Relief.
- Provide a statement to USP indicating in which country or countries the drug product and/or drug substance has been approved and is legally marketed.
- Follow USP's Guideline for Submitting Requests for Revision to the USP–NF and label the Request "SALMOUS."
- Inform USP if an application for approval of the drug product is filed in U.S. or if the approval status of the drug product or drug substance elsewhere changes.
Process
- SALMOUS monographs will not be published in Pharmacopeial Forum for comment, nor will they appear when final in USP–NF. Instead, a proposed monograph will be published in draft on USP's
Web site, and a 90–day comment period will commence. Following the comment
period and review and approval by the USP Council of Experts (including
incorporation of public comments as deemed appropriate), the final monograph
will be posted
on USP's Web site. The Nomenclature Expert Committee will not review the
title of the monograph at this time (unless the monograph also qualifies as
a Pending Standard under USP 's
Pending Standards Guideline), but may review the title in the future if a USP,
NF or Pending Standard is proposed for the article.
- When final, a SALMOUS monograph will be considered authorized rather than official text because it has been approved by the USP Council of Experts but is not part of an official compendium (USP or NF) of the U.S.
- Manufacturers of drug substances or drug products may use the designation "S–USP" on
certificates of analysis or on container labels, respectively, to indicate
compliance to the documentary standards for their drug products or drug
substances.
Table 1. Neglected Diseases and HIV/AIDS
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Diseases
|
Drug Therapy
|
|
African trypanosomiasis1
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eflornithine, melarsoprol, pentamidine, suramin
|
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Dengue
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none,
supportive
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Hemorrhagic fever with renal syndrome (HFRS) due to Hantavirus
|
ribavirin, supportive
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Lassa fever
|
ribavirin, supportive
|
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Leishmaniasis
|
amphotericin B (liposomal), meglumine antimoniate, miltefosine, pentamidine, sodium stibogluconate, paromomycin
|
|
Malaria2
|
amodiaquine, artemether,
artemether + lumefantrine,
dihydroartemisinin + piperaquine (awaiting completion of phase III trials and regulatory approvals), artemisinin, artemotil, artenimol, artesunate,
artesunate + amodiaquine (awaiting completion of phase III trials and regulatory approvals),
artesunate + mefloquine (awaiting completion of phase III trials and regulatory approvals), chloroquine, doxycycline, halofantrine, hydroxychloroquine, mefloquine, primaquine, proguanil, pyrimethamine, quinine, sulfadoxine + pyrimethamine
|
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Schistosomiasis
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metrifonate, oxamniquine, praziquantel
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Tuberculosis
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amikacin, aminosalicylic acid (PAS), capreomycin, cycloserine, ethambutol, ethionamide, isoniazid, kanamycin, levofloxacin, pyrazinamide, rifabutin, rifampin, rifapentin, streptomycin, thiacetazone, ethambutol + isoniazid, rifampin + isoniazid, rifampin + isoniazid + pyrazinamide, rifampin + isoniazid + pyrazinamide + ethambutol,
gatifloxacin, moxifloxacin
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Chagas disease (American trypanosomiasis)
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benznidazole, nifurtimox
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Leprosy
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dapsone + rifampicin + clofazimine
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Lymphatic filariasis
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albendazole, diethylcarbamazine
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Onchocerciasis
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ivermectin
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HIV/AIDS
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abacavir, amprenavir, atazanavir,
darunavir,delavirdine, didanosine, efavirenz,
efavirenz + emtricitabine + tenofovir, emtricitabine, enfuvirtide, fosamprenavir, indinavir, lamivudine, lamivudine + stavudine, lamivudine + zidovudine, lopinavir, lopinavir + ritonavir, nelfinavir, nevirapine, ritonavir, saquinavir, stavudine, stavudine + lamivudine + efavirenz, stavudine + lamivudine + nevirapine, tenofovir, tipranavir, zalcitabine, zidovudine, zidovudine + lamivudine + nevirapine, zidovudine + lamivudine + abacavir, zidovudine + lamivudine + efavirenz
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Table 2. AIDS-associated opportunistic infections
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Diseases
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Preferred Therapy
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Pneumocystis jiroveci pneumonia (PCP)
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trimethoprim-sulfamethoxazole, dapsone, dapsone + pyrimethamine + leucovorin, pentamidine, atovaquone
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Toxoplasma gondii encephalitis (TE)
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pyrimethamine + sulfadiazine + leucovorin, clindamycin + pyrimethamine + leucovorin, atovaquone ± pyrimethamine + leucovorin
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Cryptosporidiosis
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symptomatic treatment of diarrhea, and antiretrovirals
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Microsporidiosis
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albendazole, fumagillin
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Mycobacterium tuberculosis (MTB)
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isoniazid + rifampin, rifabutin + pyrazinamide + ethambutol, rifabutin (See also Table 1)
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Mycobacterium avium complex disease
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clarithromycin + ethambutol ± rifabutin, azithromycin + ethambutol ± rifabutin
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Bacterial pneumonia3
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amoxicillin (high dose),
amoxicillin + clavulanate,
ampicillin (high dose), ampicillin + sulbactam,cefotaxime, ceftriaxone,
cefpodoxine, cefuroxime, cefepime,
imipenem,
meropenem,
doxycycline,
ciprofloxacin,gatifloxacin, levofloxacin, moxifloxacin, azithromycin, erythromycin,
clarithromycin, piperacillin + tazobactam,
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Salmonellosis
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ciprofloxacin
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Campylobacter jejuni infections
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ciprofloxacin, azithromycin, aminoglycoside (e.g., gentamicin)
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Shigellosis4
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fluoroquinolone
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Bartonella infections
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macrolides
(eg. erythromycin, clarithromycin, azithromycin,) doxycycline
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Treponema pallidum infection (Syphilis)
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benzathine penicillin, aqueous crystalline penicillin,
doxycycline,
ceftriaxone
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Candidiasis (mucosal)
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fluconazole, itraconazole, clotrimazole, nystatin, voriconazole, caspofungin
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Cryptococcus neoformans meningitis
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amphotericin B deoxycholate, liposomal ampnotericin B, flucytosine, fluconazole
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Histoplasma capsulatum infections
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amphotericin B deoxycholate, liposomal amphotericin B, itraconazole
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Coccidiodomycosis
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amphotericin B deoxycholate, fluconazole, itraconazole
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Invasive aspergillosis
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voriconazole,
amphotericin B, caspofungin, itraconazole
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Cytomegalovirus (CMV) disease
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ganciclovir, valganciclovir, foscarnet
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Herpes simplex virus (HSV) disease
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famciclovir, valaciclovir, acyclovir, trifluridine
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Varicella zoster virus (VZV) disease
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acyclovir, valaciclovir, famciclovir, foscarnet
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Human papilloma virus disease
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podofilox, imiquimod
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Hepatitis C virus (HCV) disease
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peg-interferon alfa-2b, peg-interferon alfa-2a + ribavirin
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Hepatitis B virus (HBV) disease
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none recommended as preferred treatment because of lack of controlled trial data on the use of antiviral agents against HBV in HIV/HBV co-infected patients
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Penicilliosis
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amphotericin B + itraconazole
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Leishmaniasis
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pentavalent antimony, sodium stibogluconate (See also Table 1)
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Paracoccidioidomycosis
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amphotericin B, itraconazole
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Isospora belli infection
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trimethoprim + sulfamethoxazole
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Chagas disease
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benznidazole (See also Table 1) nifurtimox
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| 1. |
For african trypanosomiasis, DB289 is a future drug in Phase III trials. |
| 2. |
For artemisinin derivatives, only artemisinin-based combination therapies (ACT) should be considered for treatment of malaria to prevent drug resistance with the exception of rectal artesunate, a monotherapy for pediatric in the treatment of malaria. |
| 3. |
For the drugs used in the treatment of community-acquired pneumonia in adults, see the guidelines developed by the American Thoracic Society at http://www.thoracic.org |
| 4. |
Symptomatic treatment should be used unless severe, but should remember that hemolytic-uremic syndrome may follow fluroquinolone use. |
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