ucm054806

ucm054806 - DEPARTMENT OF HEALTH HUMAN SERVICES Public...

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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Mr. Michael D. Becker President and Chief Executive Officer Cytogen Corporation 650 College Road East Suite 3100 Princeton, NJ 08540 Re: NDA# 20-570 Quadramet® (Samarium SM 153 Lexidronam) Injection MACMIS# 13449 WARNING LETTER Dear Mr. Becker: The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a direct- to-consumer (DTC) broadcast radio advertisement (ad) (Q-0119-05), patient testimonial video (Q- 0095-05), and website (www.quadrametus.com) for Quadramet (Samarium SM 153 Lexidronam) Injection submitted by Cytogen Corporation (Cytogen) under cover of Form FDA 2253. These promotional pieces overstate the effectiveness of Quadramet and fail to reveal and minimize important risk information associated with the use of Quadramet. Therefore, the promotional pieces misbrand Quadramet within the meaning of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §§ 352(a) & (n); 321(n), and FDA implementing regulations. See 21 CFR 202.1(e). These violations are extremely concerning from a public health perspective because they overpromise the benefits and minimize the risks of Quadramet to a very sick and vulnerable population. DDMAC has previously objected, in an untitled letter dated November 9, 2001, to your dissemination of Quadramet promotional material that made unsubstantiated efficacy claims. We are very concerned that you are continuing to promote Quadramet in a violative manner. Background The Indications section of the approved product labeling (PI) for Quadramet states: “Quadramet is indicated for relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.” Quadramet is associated with several important warnings and precautions. For example, the PI for Quadramet contains the following important risk information:
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Michael D. Becker Cytogen NDA# 20-570 Page 2 WARNINGS: QUADRAMET causes bone marrow suppression. In clinical trials, white blood cell counts and platelet counts decreased to a nadir of approximately 40% to 50% of baseline in 123 (95%) of patients within 3 to 5 weeks after QUADRAMET, and tended to return to pretreatment levels by 8 weeks…Because of the unknown potential for additive effects on bone marrow, QUADRAMET should not be given concurrently with chemotherapy or external beam radiation therapy unless the clinical benefits outweigh the risks…Blood counts should be monitored weekly for at least 8 weeks, or until recovery of adequate bone marrow function. Furthermore, the Information for Patients section of the PI contains special instructions for patients receiving Quadramet therapy: Information for Patients Patients who receive QUADRAMET ® should be advised that for several hours following administration, radioactivity will be present in excreted urine. To help protect themselves and others in their environment, precautions need to be taken for 12 hours
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This note was uploaded on 01/01/2012 for the course PHAR 6010 taught by Professor Mullis during the Spring '11 term at UGA.

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ucm054806 - DEPARTMENT OF HEALTH HUMAN SERVICES Public...

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