Cycloserine by Macleods Pharmaceuticals Limited CYCLOSERINE capsule

Cycloserine by

Drug Labeling and Warnings

Cycloserine by is a Prescription medication manufactured, distributed, or labeled by Macleods Pharmaceuticals Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Product
Seromycin (cycloSERINE) capsule, 250 mg	cycloSERINE capsule, 250 mg

 The barcode may not register accurately on the U.S. scanning systems.  Alternative procedures should be followed to assure that the correct drug product is being used and administered to individual patients.  For example, institutions should consider manually inputting the product into their systems and confirm that barcode systems do no provide incorrect information when the product is scanned. 

Please refer to the package insert for the FDA-approved cycloSERINE capsules for full prescribing information, including the Warning section for risk of CNS toxicity.

The product comparison table below highlights the differences between the FDA-approved SEROMYCIN (cycloSERINE) capsules and the imported cycloSERINE capsules.

To place an order, or if you have any questions about the information contained in this letter or the use of cycloSERINE capsules, 250 mg, please contact Macleods at 1-888-943-3210 between the hours of 8 a.m. and 5 p.m. (ET), or email at safety@macleodspharma.com.

To report adverse events or quality problems associated with the use of this product, please call Macleods at 1-888-943-3210 between the hours of 8 a.m. and 5 p.m. (ET), or email at safety@macleodspharma.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

 Complete and submit the report Online: www.fda.gov/medwatch/report.htm
 Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htmor call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178)

We urge you to contact our Medical Information Department at 1-888-943-3210 between the hours of 8 a.m. and 5 p.m. (ET), or email safety@macleodspharma.com. If you have any questions about the information contained in this letter or the safe and effective use of CycloSERINE capsules.

Sincerely,

Dr Ashish Mungatiwar
Executive President
Medical Services
Macleods Pharmaceuticals

 Comparison Table

 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cycloserine capsules USP, 250 mg

Pack Count: 30's carton pack                            
NDC  33342-462-06

INGREDIENTS AND APPEARANCE

CYCLOSERINE 
cycloserine capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 33342-462
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CYCLOSERINE (UNII: 95IK5KI84Z) (CYCLOSERINE - UNII:95IK5KI84Z)	CYCLOSERINE	250 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
TALC (UNII: 7SEV7J4R1U)
GELATIN (UNII: 2G86QN327L)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARMOISINE (UNII: DR4641L47F)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	RED (Maroon cap) , RED (Maroon body)	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33342-462-06	3 in 1 CARTON	01/18/2019
1	NDC: 33342-462-66	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		01/18/2019

Labeler - Macleods Pharmaceuticals Limited (862128535)