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Good Broly
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(post #4)
Just found this on an FDA web page.... Basically it says that Nutropin Depot offers less "growth" than everyday injections...
Released by FDA: 7/28/00. Posted by FDA: 8/2/00
Robert L. Garnick, Ph.D.
Vice President, Regulatory Affairs
Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080-4990
RE: NDA # 21-075
Nutropin Depot [somatropin (rDNA origin) for injectable suspension]
MACMIS ID# 9082
Dear Dr. Garnick:
This letter refers to Genentech Incorporated’s (Genentech) May 16, 2000 submission to the Division of Drug Marketing, Advertising, and Communications (DDMAC) under cover of Form FDA 2253 of a Healthcare Professional In- Service Resource Kit (item number 7223300) for Nutropin Depot. DDMAC, in consultation with the Division of Metabolic and Endocrine Drug Products, has reviewed the Resource Kit and has determined that it is in violation of the Federal Food, Drug, and Cosmetic Act and its implementing regulations. Specifically, we object for the following reasons:
Misleading Claims
Genentech presents the claim “Nutropin Depot represents a significant advance in terms of convenience over other currently available growth hormone replacement therapies.” This claim is misleading because it implies comparable efficacy to daily growth hormone therapies along with the increased convenience of a once or twice monthly regimen. This implication is misleading because it does not convey the material information provided in the approved product labeling (Pl) that growth rates for the long-acting formulation may not be comparable to those achieved with the daily formulation. Historical studies showed growth rates achieved on daily therapy are higher for treatment-naive patients. Also, according to the Pl, patients previously treated with daily growth hormone who were switched to Nutropin Depot experienced a decrease in growth rate. This decrease was of a higher magnitude than could be accounted for by the normal decrease experienced by patients who remain on a daily regimen.
The claim that Nutropin Depot is “the first long-acting dosage form of somatropin” is misleading because it implies a greater usefulness than has been demonstrated by substantial evidence. Nutropin Depot is only indicated for the long-term treatment of growth failure due to a lack of adequate endogenous GH secretion. Because there are other forms of somatropin that are approved for additional indications, this claim misleadingly implies that Nutropin Depot can be used in place of any other somatropin for any other indication.
Lack of Fair Balance
The Resource Kit contains effectiveness claims that are not fairly balanced with information regarding contraindications, warnings, precautions, and adverse reactions. Risk information should appear with a prominence and readability reasonably comparable to the presentation of information relating to the effectiveness of Nutropin Depot. For example, the 30-page handbook for caregivers and patients presents numerous efficacy claims for Nutropin Depot therapy. Risk information is only presented on 3 pages of the booklet and the information is inadequate to fully convey the risks of Nutropin Depot therapy. No information is presented regarding contraindications and warnings. Furthermore, your presentation of information regarding injection-site reactions minimizes the frequency and magnitude of their occurrence.
Requested Action
Genentech should immediately cease dissemination of this violative material and any other promotional materials with the same or similar claims or representations. You should respond to this letter by August 11, 2000. We request that you respond, in writing, with your intent to comply with the above. Your response should also include a list of all identified violative material and the proposed method and date for discontinuing their use.
Genentech should direct the correspondence to the undersigned by facsimile at (301) 594-6771, or at the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications, HFD-42, Rm. 17B-20, 5600 Fishers Lane, Rockville, MD 20857.
DDMAC reminds you that only written communications are considered official. In all future correspondence regarding this matter, please refer to MACMIS #9082 and the NDA number.
Sincerely,
Margaret M. Kober, R.Ph.
Regulatory Review Officer
Division of Drug Marketing,
Advertising and Communications
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Good Broly
Registered: Jul 2001
Location: Central, New Jersey
Posts: 178
Gender: ?
Country:
Offline
(post #4)
Just found this on an FDA web page.... Basically it says that Nutropin Depot offers less "growth" than everyday injections...
Released by FDA: 7/28/00. Posted by FDA: 8/2/00
Robert L. Garnick, Ph.D.
Vice President, Regulatory Affairs
Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080-4990
RE: NDA # 21-075
Nutropin Depot [somatropin (rDNA origin) for injectable suspension]
MACMIS ID# 9082
Dear Dr. Garnick:
This letter refers to Genentech Incorporated’s (Genentech) May 16, 2000 submission to the Division of Drug Marketing, Advertising, and Communications (DDMAC) under cover of Form FDA 2253 of a Healthcare Professional In- Service Resource Kit (item number 7223300) for Nutropin Depot. DDMAC, in consultation with the Division of Metabolic and Endocrine Drug Products, has reviewed the Resource Kit and has determined that it is in violation of the Federal Food, Drug, and Cosmetic Act and its implementing regulations. Specifically, we object for the following reasons:
Misleading Claims
Genentech presents the claim “Nutropin Depot represents a significant advance in terms of convenience over other currently available growth hormone replacement therapies.” This claim is misleading because it implies comparable efficacy to daily growth hormone therapies along with the increased convenience of a once or twice monthly regimen. This implication is misleading because it does not convey the material information provided in the approved product labeling (Pl) that growth rates for the long-acting formulation may not be comparable to those achieved with the daily formulation. Historical studies showed growth rates achieved on daily therapy are higher for treatment-naive patients. Also, according to the Pl, patients previously treated with daily growth hormone who were switched to Nutropin Depot experienced a decrease in growth rate. This decrease was of a higher magnitude than could be accounted for by the normal decrease experienced by patients who remain on a daily regimen.
The claim that Nutropin Depot is “the first long-acting dosage form of somatropin” is misleading because it implies a greater usefulness than has been demonstrated by substantial evidence. Nutropin Depot is only indicated for the long-term treatment of growth failure due to a lack of adequate endogenous GH secretion. Because there are other forms of somatropin that are approved for additional indications, this claim misleadingly implies that Nutropin Depot can be used in place of any other somatropin for any other indication.
Lack of Fair Balance
The Resource Kit contains effectiveness claims that are not fairly balanced with information regarding contraindications, warnings, precautions, and adverse reactions. Risk information should appear with a prominence and readability reasonably comparable to the presentation of information relating to the effectiveness of Nutropin Depot. For example, the 30-page handbook for caregivers and patients presents numerous efficacy claims for Nutropin Depot therapy. Risk information is only presented on 3 pages of the booklet and the information is inadequate to fully convey the risks of Nutropin Depot therapy. No information is presented regarding contraindications and warnings. Furthermore, your presentation of information regarding injection-site reactions minimizes the frequency and magnitude of their occurrence.
Requested Action
Genentech should immediately cease dissemination of this violative material and any other promotional materials with the same or similar claims or representations. You should respond to this letter by August 11, 2000. We request that you respond, in writing, with your intent to comply with the above. Your response should also include a list of all identified violative material and the proposed method and date for discontinuing their use.
Genentech should direct the correspondence to the undersigned by facsimile at (301) 594-6771, or at the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications, HFD-42, Rm. 17B-20, 5600 Fishers Lane, Rockville, MD 20857.
DDMAC reminds you that only written communications are considered official. In all future correspondence regarding this matter, please refer to MACMIS #9082 and the NDA number.
Sincerely,
Margaret M. Kober, R.Ph.
Regulatory Review Officer
Division of Drug Marketing,
Advertising and Communications
Edit Sig | Report this post to a moderator | IP: Logged
Today 12:27 PM
All times are GMT -4 hours. The time now is 05:39 PM.
Last Thread Next Thread
Elite Quick Reply
Your Reply:
[check message length]
Show Printable Version | Email this Page | Subscribe to this Thread
Forum Jump:
Please select one: -------------------- Private Messages User Control Panel Who's Online Search Forums Photo Galleries Forums Home -------------------- Elite Fitness Anabolic-- Anabolic Discussion Board-- Counterfeit Discussion Board-- Gear Pictures Board-- Anabolics and HIV Discussion BoardElite Fitness Platinum-- Platinum Hardcore-- Best of Elite Fitness-- My Online Journal-- Bodybuilding and the Law -- Open to Everyone-- Platinum Chemistry -- Coming SoonElite Fitness-- Diet Discussion Board-- Muscle Food-- Life Extension Board-- Pictures of the Pros-- Power Lifting-- Professional and Collegiate Sports Board-- Supplements sponsored by EliteFitnessNutrition.com-- Training Discussion Board-- Women's Discussion Board-- Elite Fitness En EspañolElite Fitness Lifestyle-- Chat & Conversation-- Pictures of Our Members-- Clubs, Bars, Circuit Parties and Going Out-- Style, Fashion and Grooming-- Music-- Gambling and CasinosElite Between the Sheets-- Elite Between the Sheets-- Pictures of Women-- Pictures of MenModerators Forum
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