CYCLOSERINE - cycloserine capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

CYCLOSERINE (UNII: 95IK5KI84Z) (CYCLOSERINE - UNII:95IK5KI84Z)

Доступна з:

Macleods Pharmaceuticals Limited

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Статус Авторизація:

Unapproved drug for use in drug shortage

Характеристики продукта

CYCLOSERINE - CYCLOSERINE CAPSULE
MACLEODS PHARMACEUTICALS LIMITED
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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DISPENSE A COPY OF THE DEAR HEALTHCARE PROFESSIONAL LETTER WITH EACH
BOX
IMPORTANT PRESCRIBING INFORMATION:
CYCLOSERINE CAPSULES
HEALTH CARE PROVIDER LETTER SECTION
Subject: Temporary importation of cycloSERINE, 250 mg capsules to
address shortage
January 07, 2019
Dear Healthcare Professional,
Due to an anticipated shortage of SEROMYCIN® - cycloSERINE capsules,
250mg in the United States
(U.S.) market by the end of 2018, Macleods Pharmaceuticals Limited,
India (Macleods) is co-ordinating
with the U.S. Food and Drug Administration (FDA) to increase the
availability of cycloSERINE
capsules, 250mg for patients in the United States. Macleods has
initiated temporary importation of
cycloSERINE capsules, 250 mg into the United States market. This drug
product is marketed globally
and is manufactured in India.
At this time no other entity except Macleods is authorized by the FDA
to import cycloSERINE
capsules, 250 mg in the United States. FDA has not approved Macleods
cycloSERINE capsules, 250 mg
in the United States.
Effective immediately, and during this temporary period, Macleods will
offer the following version:
PRODUCT NAME AND DESCRIPTION
QUANTITY/PACKAGING
NDC
CYCLOSERINE CAPSULES, 250MG
30 CAPSULES, NON-CHILD RESISTANT
PACKS OF 3X10
NDC 33342-462-06
It is important to note the following:
• The imported product and U.S. FDA-approved product (SEROMYCIN®)
contain the same active
ingredient (cycloSERINE), strength (250 mg), and dosage form
(capsules).
• Please note the difference in the imported capsules’ appearance.
The imported cycloSERINE capsule
is maroon-colored. The U.S.FDA-approved SEROMYCIN® (cycloSERINE)
capsule has an opaque
red cap and opaque grey body and is imprinted with “CHAO” and
“F04”.
U.S. FDA APPROVED PRODUCT
IMPORTED PROD