DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration Silver Spring, MD 20993
TRANSMITTED BY FACSIMILE
Richard Fosko, RPh, MPH, Director Regulatory Affairs
Meda Pharmaceuticals, Inc.
265 Davidson Avenue, Suite 300
Somerset, NJ 08873-4120
RE: NDA #20-114
ASTELIN®(azelastine hydrochloride) Nasal Spray
MACMIS #18201
Dear Mr. Fosko:
As part of its routine monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a waiting room sign (sign), entitled “Astelin ‘House Cleaning’ Waiting Room Sign” (ID AST8079), for ASTELIN® (azelastine hydrochloride) Nasal Spray (Astelin) submitted by Meda Pharmaceuticals Inc. (Meda) under cover of Form FDA 2253 (2253). The sign is misleading because it omits and minimizes important risk information associated with the use of Astelin, broadens the indication, and overstates the efficacy of the drug. Thus, the sign misbrands Astelin in violation of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 352(a) & 321(n). Cf. 21 CFR 202.1(e)(5), (6)(i) & (7)(viii).
Broadening of Indication
The sign is misleading because it implies that Astelin is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience. Specifically, it prominently presents the headline, “Allergic to house cleaning?” and suggests Astelin will treat this condition. House cleaning is typically associated with exposure to perennial allergens such as dust mites, molds, and pet dander. Astelin is not approved to treat perennial allergens associated with perennial allergic rhinitis, therefore please stop implying it will cure house cleaning allergy.
DDMAC requests that Meda immediately cease the dissemination of violative promotional materials for Astelin such as those described above. Please submit a written response to this letter on or before February 9, 2009, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) in use for Astelin that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials.
Please direct your response to me at the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, 5901-B Ammendale Road, Beltsville, MD 20705-1266, facsimile at 301-847-8444. In all future correspondence regarding this matter, please refer to MACMIS #18201 in addition to the NDA number. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Astelin comply with each applicable requirement of the Act and FDA implementing regulations.
Sincerely,
{See appended electronic signature page}
Robyn Tyler, Pharm.D., J.D. Regulatory Review Officer Division of Drug Marketing, Advertising, and Communications
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Application Submission
Submitter Name Product Name
Type/Number Type/Number
NDA-20114 ORIG-1 MEDA ASTELIN NASAL SPRAY
PHARMACEUTICA
LS INC
This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature.
/s/
ROBYN C TYLER 01/26/2010
