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Drug Efficacy Report
Drug Efficacy Reports
"¥ The following data have been compiled from FDA Drug Efficacy Reports-covering the period March 12, 1969 to April 10, 1969-which report the find. ings of the National Academy of Sciences-National Research Council study of the efficacy of drugs marketed from 1938 to 1962. Indicated FDA action is not official and is subject to normal administrative hearing procedures.
product
NDA holder
proposed FDA action
Calcium gluceptate injection (cal· cium 0.09 gm/5 ml)
Lilly (Indianapolis, Ind.)
Request label changes.
Darvon capsules (propoxyphene hydrochloride 32 and 65 mg) Darvon Compound capsules (pro· poxyphene hydrochloride 32 mg, aspirin 227 mg, phenacetin 162 mg, caffeine 32.4 mg) Darvon Compound-65 capsules (propoxyphene hydrochloride 65 mg, aspirin 227 mg, phenace· tin 162 mg, caffeine 32.4 mg)
Lilly (Indianapolis, Ind.)
Request label changes and submission of supplemental new drug application.
Dextran 706% in sodium chloride solution
Abbott (N. Chicago, III.) Baxter (Morton Grove, III.) Cutter (Berkeley, Calif.) Pharmachem (Bethlehem, Pa.) Sherman (Detroit, Mich.)
Request change in labeling and submission of supplemental new drug application; additional data to support some claims.
Frenquel (azacyclonol hydrochloride) injection 5 mg/ml tablets 20 and 100 mg
Merrell (Cincinnati, Ohio)
Withdraw approval of new drug application.
Furadantin oral suspension (nitrofurantoin 5 mg/ml) Furadantin tablets (nitrofurantoin 50 and 100 mg) Furadantin Sodium sterile for intravenous use (nitrofurantoin sodium 180 mg/vial)
Eaton (Norwich, N.Y.)
Request label changes and submission of supplemental new drug application.
NAS-NRC rating and summary of fi nding s
Effective for the treatment of hypocalcemia and in prevention of hypocalcemia during ex· change transfusions. Possibly effective for antispasmodic action in treatment of intestinal, ureteral and biliary colic; abdominal pain, diarrhea and tenesums of intestinal tuberculosis; activation of uterine contractions when insensitivity to oxytocic drugs is due to calcium deficiency.
Effective for the relief of mild t o moderate
pain when administered in adequate dosage.
Effective for emergency treatment of shock or impending shock due to he1TUJrrhage, burns, surgery or other trauma. Possibly effective for nephrosis, toxemia of late pregnancy and emergency treatment of hypotension resulting from neurogenic shock. Ineffective for the too inclusive claim-treat· ment of shock due to any cause.
Ineffecti~
for all labeled
indications and
drug actions.
Effective in the treatment of pyelonephritis,
pyelitis and cystitis due to susceptible E. Coli, enterococci, S. aureus (without associated abscesses), and, although less predictably, pyelonephritis, pyelitis and cystitis due to certain strains of Klebsiella-Aerobacter, Proteus and Pseudomonus. Probably effective in the treatment of the above when due to gram-negative aerobic bacilli other than those listed above. Ineffective for other types of genito-urinary infections, such as prostatitis.
FDA proposes removal of 78 antibiotic-containing drugs
T
he Food and Drug Administration has released a list of 78 antibiotic-containing drug products which it intends to remove from the market as a result of recommendations made by the National Academy of Sciences-National Research Council, which is evaluating the effectiveness of the new drugs marketed from 1938 to 1962. The majority of the products are antibiotic-sulfa combinations in tablet, capsule or liquid form. Also included are 16 penicillin-streptomycin combinations that are administered by injection. The products are manufactured by 21 firms. Generally, the 78 products were found ineffective as fixed combinations, and FDA emphasized that this does not
286
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
necessarily mean that either the antibiotics or other active ingredients are ineffective when used alone. Early industry reaction indicates the affected firms will vigorously protest the FDA action. Industry spokesmen point to the wide use of combination products by practicing physicians and cite studies now underway which they be· lieve will invalidate the NAS-NRC recommendations. Due to indications of protracted legal proceedings between FDA, the affected companies and the Phannaceutical Manufacturers Association, the APhA Journal is withholding pub· lication of the 78 products in the "Drug Efficacy Reports" compilation pending further developments.
product
NDA holder
proposed FDA action
NAS-NRC rating and summary of findings
Itrumil Sodium tablets (iothiouracil sodium 50 mg)
Ciba (Summit, N.J.)
Request label changes and submission of supplemental new drug application.
Effective for the treatment of mild hyper-
Kaogamin dental sublingual hemostat (in each 4 minims: ethyl oxalate 0.0324 gm, ethyl malonate 0.0154 gm)
Chatham (Newark, N.J.)
Regard as misbranded since no new drug application has been approved for this product.
Ineffective for all labeled indications.
Kaogamin parenteral hemostat (in each ml: oxalic acid 5 mg, malonic acid 2.5 mg)
Chatham (Newark, N.J.)
Withdraw approval of new drug application.
Ineffective for all labeled indications.
Nitrofurantoin tablets 100 mg
Zambon (Milano, Italy)
Request ~b~changesand submission of supplemental new drug application.
See "Furadantin" on page 286.
Propylthiouracil tablets USP 50 mg
Abbott (N. Chicago, III.) Cole (St. Louis, Mo.) Lederle (Pearl River, N.Y.) Parke-Davis (Detroit, Mich.) Rexall (Los Angeles, Calif.) Upjohn (Kalamazoo, Mich.)
Request~b~changesand
Effective for the treatment of hyperthyroidism and to ameliorate hyperthyroidism in preparation for subtotal thyroidectomy or radioactive iodine therapy. Possibly effective for thyroiditis.
Protamide injection (denatured proteolytic enzyme colloidal solution)
Sherman (Detroit, Mich.)
Request submission of supplemental new drug application.
Possibly effective for the indication ophthalmic herpes zoster. Lack of substantial evidence of effectiveness for neuritis, herpes zoster and tabes dorsalis.
Tapazole tablets (methimazole 5.15 mg and 10.3 mg)
Lilly (Indianapolis, Ind.)
Request label changes and submission of supplemental new drug application.
EffectiV'e for the treatment of hyperthyroidism and to ameliorate hyperthyroidism in pre paration for subtotal thyroidectomy of radioactive iodine therapy.
submission of supplemental new drug application.
thyroidism.
extending the pharmacist's knowledge ~
Extension. services in pharmacy and the school of pharmacy of the University of Wisconsin "will offer three. week-long training courses for BS-Ievel technicians in product development and analytical laboratory work, according to William L. Blockstein, professor and extension chairman. First two courses, combining lectures and laboratory exercises are "Aspects of Pharmaceutical Development I":'" Solutions" and "II.;;Disperse Systems." First course, set for June 16-20 repeats a similar course first offered in 1968. The second course, June 23-27, is a logical development of a sequence that will advance competence of workers in the liquid dosage forms. Thuro Carstensen will offer both courses. August 18-22 are the dates for "Electrometric Methods of Analysis," for analytical workers in the industry. This course follows two previous courses offered in 1967 and 1968, which dealt with spectroscopic analytical methods. John J. Windheuser and John H. Perrin will be instructors. More information may be obtained from William L. Blockstein, Extension Services in Pharmacy, University Extension, The University of Wisconsin, Room 190, Pharmacy Building, Madison, WI 53706. ~ The Maryland Society of Hospital Pharmacists convenes June 6, 7 and 8 in Ocean City for its fourth annual hosUnder the pital pharmacy seminar. theme of "The Future of Hospital Pharmacy," discussion topics will include "A View of the Future of Clinical Pharmacy," The View From Industry," "A View of Job Dynamics," IV admixture incompatibilities, establishing a unit dose
Participants at recent seminar at Northeast Louisiana State College on pharmaceutical services to health care facilities included (seated, left to right) Jim Powell, Betty Smith, Ken Hanson and (standing, left to right) August Danti, Ben Cooper, John Benedict and' Wi/liam O'Brien.
system-a progress report, and biosta tics in pharmacy. Information is available from Robert E. Snyder, General Chairman, Maryland General Hospital, 827 Linden Avenue, Baltimore, MD 21201. ~ Four varied subjects were part of the University of Arkansas pharmacy extension course for spring, 1969. Starting on March 16, the series ran through April 13 and delved into such topi'cs as "Generic Drugs-There is a Difference," professional fee and third-party prescription programs, drug interaction and "Pharmacy in Caricature." Speakers, all from the University of Arkansas, were Robert McCowan, professor of pharmaceutics; Walter Morrison, assistant professor of pharmacy administration; Marcus Jordin, professor of pharmacology, and T.S. Grosicki, professor of pharmaceutics.
~ A five-hour seminar on drug interac-
tion and adverse drug interaction conducted by the extension service of Rutgers University college of pharmacy was attended by more than 100 pharmacists on March 27. The program, with John L. Voigt, extension service director, in charge, was sponsored by the New J ersey Pharmaceutical Association and the New Jersey Society of Hospital Phannacists. Voigt, in opening the seminar, stressed the importance of keeping abreast of developments with emphasis on possible conflict between drugs, and between a drug and certain foods. Leo Dubrow, NJPhA president, told the participants'The pharmacist, with his record of a patient's history and personal knowledge of past experience, is in the best position to warn against the hazardous combinations of drugs." Vol. NS9, No.6, June 1969
287
"¥ The following data have been compiled from FDA Drug Efficacy Reports-covering the period March 12, 1969 to April 10, 1969-which report the find. ings of the National Academy of Sciences-National Research Council study of the efficacy of drugs marketed from 1938 to 1962. Indicated FDA action is not official and is subject to normal administrative hearing procedures.
product
NDA holder
proposed FDA action
Calcium gluceptate injection (cal· cium 0.09 gm/5 ml)
Lilly (Indianapolis, Ind.)
Request label changes.
Darvon capsules (propoxyphene hydrochloride 32 and 65 mg) Darvon Compound capsules (pro· poxyphene hydrochloride 32 mg, aspirin 227 mg, phenacetin 162 mg, caffeine 32.4 mg) Darvon Compound-65 capsules (propoxyphene hydrochloride 65 mg, aspirin 227 mg, phenace· tin 162 mg, caffeine 32.4 mg)
Lilly (Indianapolis, Ind.)
Request label changes and submission of supplemental new drug application.
Dextran 706% in sodium chloride solution
Abbott (N. Chicago, III.) Baxter (Morton Grove, III.) Cutter (Berkeley, Calif.) Pharmachem (Bethlehem, Pa.) Sherman (Detroit, Mich.)
Request change in labeling and submission of supplemental new drug application; additional data to support some claims.
Frenquel (azacyclonol hydrochloride) injection 5 mg/ml tablets 20 and 100 mg
Merrell (Cincinnati, Ohio)
Withdraw approval of new drug application.
Furadantin oral suspension (nitrofurantoin 5 mg/ml) Furadantin tablets (nitrofurantoin 50 and 100 mg) Furadantin Sodium sterile for intravenous use (nitrofurantoin sodium 180 mg/vial)
Eaton (Norwich, N.Y.)
Request label changes and submission of supplemental new drug application.
NAS-NRC rating and summary of fi nding s
Effective for the treatment of hypocalcemia and in prevention of hypocalcemia during ex· change transfusions. Possibly effective for antispasmodic action in treatment of intestinal, ureteral and biliary colic; abdominal pain, diarrhea and tenesums of intestinal tuberculosis; activation of uterine contractions when insensitivity to oxytocic drugs is due to calcium deficiency.
Effective for the relief of mild t o moderate
pain when administered in adequate dosage.
Effective for emergency treatment of shock or impending shock due to he1TUJrrhage, burns, surgery or other trauma. Possibly effective for nephrosis, toxemia of late pregnancy and emergency treatment of hypotension resulting from neurogenic shock. Ineffective for the too inclusive claim-treat· ment of shock due to any cause.
Ineffecti~
for all labeled
indications and
drug actions.
Effective in the treatment of pyelonephritis,
pyelitis and cystitis due to susceptible E. Coli, enterococci, S. aureus (without associated abscesses), and, although less predictably, pyelonephritis, pyelitis and cystitis due to certain strains of Klebsiella-Aerobacter, Proteus and Pseudomonus. Probably effective in the treatment of the above when due to gram-negative aerobic bacilli other than those listed above. Ineffective for other types of genito-urinary infections, such as prostatitis.
FDA proposes removal of 78 antibiotic-containing drugs
T
he Food and Drug Administration has released a list of 78 antibiotic-containing drug products which it intends to remove from the market as a result of recommendations made by the National Academy of Sciences-National Research Council, which is evaluating the effectiveness of the new drugs marketed from 1938 to 1962. The majority of the products are antibiotic-sulfa combinations in tablet, capsule or liquid form. Also included are 16 penicillin-streptomycin combinations that are administered by injection. The products are manufactured by 21 firms. Generally, the 78 products were found ineffective as fixed combinations, and FDA emphasized that this does not
286
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
necessarily mean that either the antibiotics or other active ingredients are ineffective when used alone. Early industry reaction indicates the affected firms will vigorously protest the FDA action. Industry spokesmen point to the wide use of combination products by practicing physicians and cite studies now underway which they be· lieve will invalidate the NAS-NRC recommendations. Due to indications of protracted legal proceedings between FDA, the affected companies and the Phannaceutical Manufacturers Association, the APhA Journal is withholding pub· lication of the 78 products in the "Drug Efficacy Reports" compilation pending further developments.
product
NDA holder
proposed FDA action
NAS-NRC rating and summary of findings
Itrumil Sodium tablets (iothiouracil sodium 50 mg)
Ciba (Summit, N.J.)
Request label changes and submission of supplemental new drug application.
Effective for the treatment of mild hyper-
Kaogamin dental sublingual hemostat (in each 4 minims: ethyl oxalate 0.0324 gm, ethyl malonate 0.0154 gm)
Chatham (Newark, N.J.)
Regard as misbranded since no new drug application has been approved for this product.
Ineffective for all labeled indications.
Kaogamin parenteral hemostat (in each ml: oxalic acid 5 mg, malonic acid 2.5 mg)
Chatham (Newark, N.J.)
Withdraw approval of new drug application.
Ineffective for all labeled indications.
Nitrofurantoin tablets 100 mg
Zambon (Milano, Italy)
Request ~b~changesand submission of supplemental new drug application.
See "Furadantin" on page 286.
Propylthiouracil tablets USP 50 mg
Abbott (N. Chicago, III.) Cole (St. Louis, Mo.) Lederle (Pearl River, N.Y.) Parke-Davis (Detroit, Mich.) Rexall (Los Angeles, Calif.) Upjohn (Kalamazoo, Mich.)
Request~b~changesand
Effective for the treatment of hyperthyroidism and to ameliorate hyperthyroidism in preparation for subtotal thyroidectomy or radioactive iodine therapy. Possibly effective for thyroiditis.
Protamide injection (denatured proteolytic enzyme colloidal solution)
Sherman (Detroit, Mich.)
Request submission of supplemental new drug application.
Possibly effective for the indication ophthalmic herpes zoster. Lack of substantial evidence of effectiveness for neuritis, herpes zoster and tabes dorsalis.
Tapazole tablets (methimazole 5.15 mg and 10.3 mg)
Lilly (Indianapolis, Ind.)
Request label changes and submission of supplemental new drug application.
EffectiV'e for the treatment of hyperthyroidism and to ameliorate hyperthyroidism in pre paration for subtotal thyroidectomy of radioactive iodine therapy.
submission of supplemental new drug application.
thyroidism.
extending the pharmacist's knowledge ~
Extension. services in pharmacy and the school of pharmacy of the University of Wisconsin "will offer three. week-long training courses for BS-Ievel technicians in product development and analytical laboratory work, according to William L. Blockstein, professor and extension chairman. First two courses, combining lectures and laboratory exercises are "Aspects of Pharmaceutical Development I":'" Solutions" and "II.;;Disperse Systems." First course, set for June 16-20 repeats a similar course first offered in 1968. The second course, June 23-27, is a logical development of a sequence that will advance competence of workers in the liquid dosage forms. Thuro Carstensen will offer both courses. August 18-22 are the dates for "Electrometric Methods of Analysis," for analytical workers in the industry. This course follows two previous courses offered in 1967 and 1968, which dealt with spectroscopic analytical methods. John J. Windheuser and John H. Perrin will be instructors. More information may be obtained from William L. Blockstein, Extension Services in Pharmacy, University Extension, The University of Wisconsin, Room 190, Pharmacy Building, Madison, WI 53706. ~ The Maryland Society of Hospital Pharmacists convenes June 6, 7 and 8 in Ocean City for its fourth annual hosUnder the pital pharmacy seminar. theme of "The Future of Hospital Pharmacy," discussion topics will include "A View of the Future of Clinical Pharmacy," The View From Industry," "A View of Job Dynamics," IV admixture incompatibilities, establishing a unit dose
Participants at recent seminar at Northeast Louisiana State College on pharmaceutical services to health care facilities included (seated, left to right) Jim Powell, Betty Smith, Ken Hanson and (standing, left to right) August Danti, Ben Cooper, John Benedict and' Wi/liam O'Brien.
system-a progress report, and biosta tics in pharmacy. Information is available from Robert E. Snyder, General Chairman, Maryland General Hospital, 827 Linden Avenue, Baltimore, MD 21201. ~ Four varied subjects were part of the University of Arkansas pharmacy extension course for spring, 1969. Starting on March 16, the series ran through April 13 and delved into such topi'cs as "Generic Drugs-There is a Difference," professional fee and third-party prescription programs, drug interaction and "Pharmacy in Caricature." Speakers, all from the University of Arkansas, were Robert McCowan, professor of pharmaceutics; Walter Morrison, assistant professor of pharmacy administration; Marcus Jordin, professor of pharmacology, and T.S. Grosicki, professor of pharmaceutics.
~ A five-hour seminar on drug interac-
tion and adverse drug interaction conducted by the extension service of Rutgers University college of pharmacy was attended by more than 100 pharmacists on March 27. The program, with John L. Voigt, extension service director, in charge, was sponsored by the New J ersey Pharmaceutical Association and the New Jersey Society of Hospital Phannacists. Voigt, in opening the seminar, stressed the importance of keeping abreast of developments with emphasis on possible conflict between drugs, and between a drug and certain foods. Leo Dubrow, NJPhA president, told the participants'The pharmacist, with his record of a patient's history and personal knowledge of past experience, is in the best position to warn against the hazardous combinations of drugs." Vol. NS9, No.6, June 1969
287