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Dispense a copy of the Dear Healthcare Professional Letter with each box IMPORTANT PRESCRIBING INFORMATION: cycloSERINE Capsules | Cycloserine [Macleods Pharmaceuticals Limited] | BioPortfolio

17:46 EST 26th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

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:

 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”.

• 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

 

Product Name and Description
Quantity/Packaging
NDC
cycloSERINE Capsules, 250mg
30 Capsules, Non-Child Resistant
Packs of 3x10
NDC 33342-462-06
U.S. FDA Approved Product
Imported Product
Seromycin (cycloSERINE) capsule, 250 mg
cycloSERINE capsule, 250 mg
 


Cycloserine capsules USP, 250 mg

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

Manufacturer

Macleods Pharmaceuticals Limited

Active Ingredients

Source

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