
Unacceptable PN Letter - Spherusol

 

 
 

Our STN:  BL 125354/0                                                                                 

 

Allermed Laboratories, Inc.

Attention: H.S. Nielsen, Jr., Ph.D.                                                    

7203 Convoy Court

San Diego, CA 92111

 

Dear Dr. Nielsen:

 

We have reviewed your biologics license application (BLA) for Coccidioides immitis Spherule-Derived Skin Test Antigen and your October 6, 2009, submission to it, requesting a proprietary name review. 

 

In consultation with CBER’s Advertising and Promotional Labeling Branch, we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable regulations, your proposed name, Coccidioidin SD, is unacceptable. 

 

The proposed proprietary name is considered false or misleading. The basis for our decision is the following:

 

1. "Coccidioidin, USP” and “Coccidioidin (Spherule Derived)” were the proper names for similar skin test products. The trademarking of Coccidioidin and its use as a proprietary name would potentially impact the ability to use the proper name for other similar products. 
 

2. The name “Coccidioidin” is the USP Official Monograph for a sterile solution containing the antigens obtained from the by-products of mycelial growth or from the spherules of the fungus Coccidioides immitis. Thus, use of this term for this product may misleadingly suggest that the product is made from coccidioidin, an extract from the saprophytic mycelial form of Coccidioides immitis rather than spherulin, a component from the parasitic endosporulating spherule form of C. immitis. It has been reported that the spherulin skin test may be more sensitive than the coccidioidin skin test; therefore, these names would not seem to be interchangeable. [1] [2]


You may submit a new proprietary name for FDA consideration. Any alternate proprietary name(s) should comply with the regulations regarding false, misleading or fanciful names and should not be confused with other medicinal products with orthographic or phonological similarities.

 

If you have any questions, please contact Dr. Jon Daugherty at (301) 827-3070.

 

Sincerely yours,

 

Wellington Sun, M.D.

Director

Division of Vaccines and

Related Products Applications

Office of Vaccines

 Research and Review

Center for Biologics

Evaluation and Research





[1] Stevens DA, Levine HB, TenEyck DR: Dermal Sensitivity to Spherulin and Coccidioidin. Chest 65:530-533, 1974


[2] Federal Register, Vol. 42, No. 190, September 30, 1977, 52674-52682