Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
CYCLOSERINE (UNII: 95IK5KI84Z) (CYCLOSERINE - UNII:95IK5KI84Z)
Macleods Pharmaceuticals Limited
ORAL
PRESCRIPTION DRUG
Unapproved drug for use in drug shortage
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._ ---------- 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 Прочитајте комплетан документ