ACCUTANE (isotretinoin capsules) Rx only CAUSES BIRTH
Birth defects which have been documented following Accutane exposure include abnormalities of the Distributing only FDA approved isotretinoin product.
Accutane (isotretinoin) Capsules Label
20 juin 2002 CONTRAINDICATIONS AND WARNINGS: Accutane must not be used by ... Food and Drug Administration MedWatch Program @ 1-800-FDA-1088. Accutane ...
Medication Guide
FDA MedWatch at 1-800-FDA-1088 and. · the iPLEDGE pregnancy registr at 1-866-495-0654. 2. Serious mental health problems. Accutane may cause: · depression.
Absorica (isotretinoin) Capsules
To report SUSPECTED ADVERSE REACTIONS contact Ranbaxy
ACCUTANE (isotretinoin capsules) Rx only CAUSES BIRTH
Birth defects which have been documented following Accutane exposure include Distributing only FDA approved isotretinoin product.
NDA 18-662 S-058 Page 4 ACCUTANE (isotretinoin capsules) Rx
Any suspected fetal exposure during or 1 month after isotretinoin therapy must be reported immediately to the. FDA via the MedWatch number 1-800-FDA-1088 and
NDA 18-662/S-056 Page 11 ACCUTANE (isotretinoin capsules) Rx
Isotretinoin a retinoid
CPY Document
12 août 2005 To distribute only FDA-approved Accutane product. 3. To only ship Accutane to wholesalers registered in the iPLEDGE program with prior written ...
1 ACCUTANE (isotretinoin) CAUSES BIRTH DEFECTS AVOID
30 oct. 2001 can result if pregnancy occurs while taking Accutane in any amount even ... Food and Drug Administration MedWatch Program @ 1-800-FDA-1088.
C:DataMy DocumentsN18662043APltr
2 mai 2002 Although not every fetus exposed to Accutane has resulted in a deformed child there ... 1-800-FDA-1088. Accutane should be prescribed only ...
[PDF] ACCUTANE (isotretinoin capsules) Rx only CAUSES BIRTH
Only FDA- approved Accutane products must be distributed prescribed dispensed and used Patients must fill Accutane prescriptions only at US licensed
[PDF] Accutane (isotretinoin) Capsules Label - Accessdatafdagov
20 jui 2002 · CONTRAINDICATIONS AND WARNINGS: Accutane must not be used by females who are pregnant Although not every fetus exposed to Accutane has
[PDF] Accutane - Accessdatafdagov
15 fév 2002 · (isotretinoin) CAPSULES CAUSES BIRTH DEFECTS AVOID PREGNANCY CONTRAINDICATIONS AND WARNINGS: Accutane must not be used by females
[PDF] Absorica (isotretinoin) Capsules - Accessdatafdagov
Only FDA- approved isotretinoin products must be distributed prescribed dispensed and used Required components of the iPLEDGE Program are: • Absorica™ must
[PDF] Medication Guide - Accessdatafdagov
Accutane is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments including antibiotics · Because Accutane can cause
[PDF] highlights of prescribing information - Accessdatafdagov
ABSORICA® (isotretinoin) capsules for oral use Initial U S Approval: 1982 WARNING: CAUSES BIRTH DEFECTS See full prescribing information for complete
[PDF] accutane-medication-guidepdf
Read the Medication Guide that comes with Accutane before you start taking it and each time you get a prescription FDA MedWatch at 1-800-FDA-1088 and
iPLEDGE REMS - Home
The REMS is required by the U S Food and Drug Administration (FDA) to ensure the benefits of isotretinoin outweigh its risks
[PDF] Dermatologics: Acne Products - Isotretinoin - WAgov
1 déc 2021 · Isotretinoin is a synthetic analogue of vitamin A and is FDA indicated for the treatment of severe recalcitrant nodulocystic acne
Isotretinoin Capsules: Package Insert - Drugscom
1 oct 2022 · Isotretinoin Capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older
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