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NDA Approvals
abling diseases. These considerations, as mentioned earlier, should be equal in importance to the child's inability to remove the cap. In 1966, the FDA commissioner, at the behest of Congress, called a conference of government and industry representatives, whose task was to develop voluntary precautions against accidental ingestion of salicylates. This conference appointed an ad hoc committee which expanded its goal to include the setting of some basic performance standards for saftey closures on containers of drugs and household products. The group plans to undertake a pilot study which would develop methodology and protocol for future testing of available types of safety closures and safety packaging. a time for action It has been said that it is the manufacturer who controls the type of container and the type of closure which will be used. 6 In making a decision as to how his product will be marketed, the pharmaceutical manufacturer, for example, must consider the reaction of the public as well as the reaction of his immediate outlet, the
pharmacist. The latter, in turn, is conditioned by his patrons' reactions to the attractiveness of the container, the added cost and the possibility of increased need for shelf space. On closer examination, however, it may be the consumer who is in the controlling position. A demand for safety features on the part of the public obviously will have its effeot on the supply. There is no question that this demand will be encouraged by informational and educational programs -if not by personal experiences of the American housewife. The American Academy of Pediatrics suggests that acute ingestions of potentially toxic substances are a byproduct of rapidly advancing technology, " . .. certainly related to aggressive advertising." One physician active in the field of poison control has put it even more strongly-" ... legislative action to control the closure hazards of marketable household products can be drafted . . . . " 6 This remark turns out to be an omen. Since it was made, bills along these lines have already been introduced in the U.S. Congress. A proposed amendment to the Hazardous Substances Act -known as the "Safe Packaging Act"-
provides for the promulgation of regulations ". . . establishing standards for the packaging of any toxic household substance, or any class or kind of such substances, designed to prevent or substantially reduce the hazard of serious personal injury or illness to children reasonably likely to handle, use or ingest ·a ny such substance . . .." 7 In ,t he words of one official, "It behooves us all to look to the future to make sure by research and development that we do everything possible to provide safety in the use of home medicines." 4 It would seem that the future has arrived. • references 1. Seventh Annual R eport, National Planning Council for National Poison Prevention Week March 17- 23, 1 (1968) , 2. "S tatistical Analysis of Ingestion Experience Reported to the N alional Clearinghouse, 1966," National Clearinghouse for Poison Control Centers Bull., 6 (July-Aug. 1967) 3 . Cann, Howard, M., MD, et . al., 14Epidemio_ logic Aspects of Poisoning Accidents," Am. J. of Pub. H ealth, 50, No. 12, 1920 (Dec. 1960) 4. Turk, John G., R esearch and Development in Safety Closures, committee on scientific development, The Proprietary Association, 11 (Dec. 8, 1966) 5. Arena, Jay M. , MD, "Safety Closure Caps," JAMA , 169, No. 11, 1187 (March 14, 1959 ) 6 . Pediatrics, 40, No.2, 159 (Aug. 1967) 7. S-3547 and HR-17355, 90th Congress, 2nd session
NDA
*** Approvals *** As provided in 1130.33 of the FDA regulations (21 CFR 130.33), notice has been given of the follow ing new drugs for which applications or ~pple mental applications for subsequent labeling changes have been approved. This list is published for information of pharmacists but it is not intended to advise On the use of the products. Drugs listed may include some now ap proved for distribution by applications but previously marketed by other firm s.
trade name
applicant
10% Gentran in 5% dextrose injection 10% Gentran 40 in 0_9% sodium chloride injection
Travenol Labs (Morton Grove, III.) Travenol Labs (M orton Grove , III.)
Neopap supprettes
William A. Webster (Memphis, Tenn.) Syntex (Palo Alto, Calif.) Syntex (Palo Alto, Calif.)
Norinyll tablets Norinyll tablets
+ 80 21 day + 80 28 day
ortho-Novum
1 mg Fe-28
tablets
Pentaerythritol tetranitrate tablets
Pentaerythritol tetra nitrate with phenobarbital tablets
Ortho Pharmaceutical (Raritan, N .J.)
American Pharmaceutica l (New York, N.Y.) Kirkman La bs (Portland, are .) Kirkman Labs (Portland, are.)
active ingred ients dextra n-40 10% in dextrose 5% dextra n -40 10% in sodium chloride 0.9% acetaminophen 2 gr norethindrone 1 mg mestranol 0.08 mg 21 tablets: norethindrone 1 mg mestranol 0.08 mg 7 tablets: inert 21 tablets: norethindrone 1 mg mestranol 0.05 mg 7 tablets: ferrous fumarate 75 mg pentaerythritol tetra nitrate 10 and 20 mg pentaerythritol tetra nitrate 10and20mg phenobarbital 1/. gr
how dispensed
principal indication
date approved
extracorporeal circulation extracorporeal circulation
11/4/68
II
antipyretic
11/7/68
II
oral contraceptive
l1/6/68
II
oral contraceptive
l1/8/68
II
oral contraceptive
10/28/68
II
a nti-a ng ina pectoris agent
10/29/68
II
anti-angina pectoris agent
10/29/68
II II
l1/4/68
pharmacist. The latter, in turn, is conditioned by his patrons' reactions to the attractiveness of the container, the added cost and the possibility of increased need for shelf space. On closer examination, however, it may be the consumer who is in the controlling position. A demand for safety features on the part of the public obviously will have its effeot on the supply. There is no question that this demand will be encouraged by informational and educational programs -if not by personal experiences of the American housewife. The American Academy of Pediatrics suggests that acute ingestions of potentially toxic substances are a byproduct of rapidly advancing technology, " . .. certainly related to aggressive advertising." One physician active in the field of poison control has put it even more strongly-" ... legislative action to control the closure hazards of marketable household products can be drafted . . . . " 6 This remark turns out to be an omen. Since it was made, bills along these lines have already been introduced in the U.S. Congress. A proposed amendment to the Hazardous Substances Act -known as the "Safe Packaging Act"-
provides for the promulgation of regulations ". . . establishing standards for the packaging of any toxic household substance, or any class or kind of such substances, designed to prevent or substantially reduce the hazard of serious personal injury or illness to children reasonably likely to handle, use or ingest ·a ny such substance . . .." 7 In ,t he words of one official, "It behooves us all to look to the future to make sure by research and development that we do everything possible to provide safety in the use of home medicines." 4 It would seem that the future has arrived. • references 1. Seventh Annual R eport, National Planning Council for National Poison Prevention Week March 17- 23, 1 (1968) , 2. "S tatistical Analysis of Ingestion Experience Reported to the N alional Clearinghouse, 1966," National Clearinghouse for Poison Control Centers Bull., 6 (July-Aug. 1967) 3 . Cann, Howard, M., MD, et . al., 14Epidemio_ logic Aspects of Poisoning Accidents," Am. J. of Pub. H ealth, 50, No. 12, 1920 (Dec. 1960) 4. Turk, John G., R esearch and Development in Safety Closures, committee on scientific development, The Proprietary Association, 11 (Dec. 8, 1966) 5. Arena, Jay M. , MD, "Safety Closure Caps," JAMA , 169, No. 11, 1187 (March 14, 1959 ) 6 . Pediatrics, 40, No.2, 159 (Aug. 1967) 7. S-3547 and HR-17355, 90th Congress, 2nd session
NDA
*** Approvals *** As provided in 1130.33 of the FDA regulations (21 CFR 130.33), notice has been given of the follow ing new drugs for which applications or ~pple mental applications for subsequent labeling changes have been approved. This list is published for information of pharmacists but it is not intended to advise On the use of the products. Drugs listed may include some now ap proved for distribution by applications but previously marketed by other firm s.
trade name
applicant
10% Gentran in 5% dextrose injection 10% Gentran 40 in 0_9% sodium chloride injection
Travenol Labs (Morton Grove, III.) Travenol Labs (M orton Grove , III.)
Neopap supprettes
William A. Webster (Memphis, Tenn.) Syntex (Palo Alto, Calif.) Syntex (Palo Alto, Calif.)
Norinyll tablets Norinyll tablets
+ 80 21 day + 80 28 day
ortho-Novum
1 mg Fe-28
tablets
Pentaerythritol tetranitrate tablets
Pentaerythritol tetra nitrate with phenobarbital tablets
Ortho Pharmaceutical (Raritan, N .J.)
American Pharmaceutica l (New York, N.Y.) Kirkman La bs (Portland, are .) Kirkman Labs (Portland, are.)
active ingred ients dextra n-40 10% in dextrose 5% dextra n -40 10% in sodium chloride 0.9% acetaminophen 2 gr norethindrone 1 mg mestranol 0.08 mg 21 tablets: norethindrone 1 mg mestranol 0.08 mg 7 tablets: inert 21 tablets: norethindrone 1 mg mestranol 0.05 mg 7 tablets: ferrous fumarate 75 mg pentaerythritol tetra nitrate 10 and 20 mg pentaerythritol tetra nitrate 10and20mg phenobarbital 1/. gr
how dispensed
principal indication
date approved
extracorporeal circulation extracorporeal circulation
11/4/68
II
antipyretic
11/7/68
II
oral contraceptive
l1/6/68
II
oral contraceptive
l1/8/68
II
oral contraceptive
10/28/68
II
a nti-a ng ina pectoris agent
10/29/68
II
anti-angina pectoris agent
10/29/68
II II
l1/4/68