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NDA Approvals
Women's Auxiliary
Womanpower and Politics The following column was written by Helen Rowland. immediate past president of the auxiliary and was published in the Journal in October 1969_ In this year of political activity and presidential elections. I feel that it is most appropriate.
~
Someone said "Don't underestimate the power of a woman." How true-that is, when we make up our minds to do a job. , What is our role in political activity as members of the Women's Auxiliary? As citizens, it is our privilege and our responsibility to elect local, county, state and national government representatives. But, it is also our obligation to help our elected officials in their lawmaking by taking an intelligent and active interest in legislation and by giving them the benefit of our views and judgment. We must assume the responsibility to tell the true story to others. Stress must be made on "each of us" because, by increasing responsibility, one person at a time, we can defeat or support those legislative measures which are so vital to pharmacy. Our job, as Auxiliary members, is first, to understand the legislation and bills; second, to discuss it with family and friends; third, to write letters to our own state legislators or congressmen when alerted to the need. Appeals should not be made in terms of our interests as pharmacists' wives but in terms of public health and general welfare.
NDA Approvals
I. Keep a directory or file of your local assemblymen and senators and of members of the assembly and senate committees on governmental efficiency and public health to which most of our bills related to pharmacy will be referred. Also do the same for your national congressmen. 2. Keep a file of all information you receive from the pharmaceutical association in your locality, other pharmaceutical groups or from periodicals and newspapers relating to bills affecting pharmacy., 3. Write to the state printing office in your state capital for copies of bills in which you are interested. Give the number and title. The U.S. Government Printing Office can supply similar copies for national legislation. 4. Study the provisions of the bills and develop a point of view. S. Prepare an argument or a series, of arguments for or against each measure. The more factual, the more reasonable and "unselfish" the arguments, the more likely they are to receive consideration. 6. Know your own legislators and congressmen, and whenever possible, make personal contacts with them. 7. Be prepared to write letters (or send telegrams) when called upon for quick action. S. If it is possible, attend committee hearings or appear at the time the bill is being presented on the floor. 9: Interest your friends in the legislation you support or oppose. 10. According to our APhA Auxiliary constitution, we cannot take any political action in the name of the Auxiliary which does not have the approval of APhA. We must follow the general directive of the Association in regard to those bills which we support or oppose in the name of the Auxiliary or where we indicate we are members of the Auxiliary. Don't hesitate to write your elected representatives if you have something to say that you think should be called to their attention. It is the straight-forward letter carrying the appeal of earnestness that commands the interest and respect of members of the state assembly and national elected officials. They never tire of hearing from constituents who have something to contribute to the welfare of the nation. Your representatives know you write to make your opinions heard and that they are your voice in Washington. Helen L Lowe 3105 Silverleaf Drive Austin, TX 78757
1**,
As provided. in /130.33 of the FDA regulations (21 CFR 130.33) notice ha.• been given of the following new drugs for which applications or supplemental 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 approved for distribution b!l applicants but previously marketed btl other firms.
Product
186
Applicant
How Dispensed
Principal Indication
Date Approved
Alcaine solution (proparacaine hydrochloride 0.5%)
Alcon (Ft. Worth, Tex.)
II
Local anesthetic
12-22-71
Ancobon capsules (flucytosine 250 mg and 500 mg)
Hoffman·La Roche (Nutley, N.J.)
II
Anti-infective for use only in the treatment of serious infections caused by susceptible strains of Candida and/or C'ryptococcus
11-26-71
Antiminth oral suspension (pyrantel pamoate ,equivalent to pyrantel 250 mg/5 ml) Catara,se sterile ophthalmic (chymotrypsin NF 300 U)
Pfizer (New York, N.Y.)
II
Anthelmintic
12-30--71
Smith, Miller & Patch (New BrunSWick, N.J.)
II
Enzymatic zonulysis for intracapsular lens extraction
12-28-71
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
Product
Applicant
How Dispensed
Principal Indication
Date Approved
Cetacort lotion (hydrocortisone 0.125%,0.25%,0.5% and 1%)
Texas Pharmacal· (San Antonio, Tex.)
ij
Anti·inflammatory
12-22-71
Chromitope sodium injection (sodium chromate Cr")
Squibb (New Brunswick, N.J.)
ij
Determination of red blood cell volume or mass
12-27-71
Cortisone acetate tablet 25 mg
Vitarine (Springfield Gardens, N.Y.) Zenith (Northvale, N.J.)
ij
Glucocorticoid
1-3-72
Cyanocobalamin injection 100 mcg/ml and 1,000 mcg/ml
Medical Chemicals (Melrose Park, III.)
ij
Vitamin
12-14-71
Folic acid injection 1 mg/ml
Gotham (Brooklyn, N.Y.)
ij
Vitamin
1-4-72
Folic acid tablet 1 mg
Danbury Pharmacal (Danbury, Conn.)
:ij
Vitamin
12-23-71
Hydrocortisone cream 0.5% and 1%
Sperti (Ft. Mitchell, Ky.)
:ij
Anti·inflammatory
12-29-71
Isoniazid tablet 100 mg and 300 mg
Dow (Zionsville, Ind.)
:ij
Antituberculosis agent
11-4-71
Lidocaine hydrochloride injection 1/,%,1% and 2%
Invenex (San Francisco, Calif.)
:ij
Anesthetic
12-29-71
Lipo·Hapin injection (in each ml: sodium heparin 1,000, 5,000, 10,000, 20,000 and 40,000 USP units)
Riker (Northridge, Calif.)
:ij
Anticoagulant
11-16-71
Lubricort cream (hydrocortisone 1%)
Texas Pharmacal (San Antonio, Tex.)
:ij
Antl·inflammatory
12-22-71
Lubricort lotion (hydrocortisone 0.25%,0.5% and 1%)
Texas Pharmacar (San Antonio, Tex.)
:ij
Anti·inflammatory
12-27-71
Meperidine hydrochloride injection 25 mg/ml, 50 mg/ml, 75 mg/ml, 100 mg/ml and 100 mg/2 ml
Knoll (Orange, N.J.)
:ij
Narcotic analgesic
12-22-71
Methyltestosterone tablet 10 mg and 25 mg
Lilly (Indianapolis, Ind.)
:ij
Androgen
12-22-71
Potassium chloride injection 10 mEq, 20 mEq, 30 mEq and 40 mEq
Travenol (Morton Grove, III.)
:ij
Electrolyte replenisher
12-22-71
Prednisone tablet 2.5 mg and 5 mg
Barrows Pharmacal (Inwood, N.Y.)
:ij
Glucocorticoid
12-23-71
Prednisone tablet 5 mg
First Texas (Dallas, Tex.)
:ij
Glucocorticoid
12-22-71
Prednisone tablet 5 mg
Zenith (Northvale, N.J.)
:ij
Adrenocortical steroid
11-16-71
Prednisolone tablet 5 mg
First Texas (Dallas, Tex.) Stayner (Berkeley, Calif.) Zenith (Northvale, N.J.) Zenith (Northvale, N.J.) Squibb (New Brunswick, N.J.) Lederle (Pearl River, N.Y.) Rachelle (Long Beach, Calif.)
:ij
Glucocorticoid
12-22-71
:ij
Analgesic
11-30-71
:ij
11-23-71
:ij
Diagnostic agent Glucocorticoid
:ij
Anticonvulsant
12-23-71
Mallinckrodt Nucleur (St. Lou is, Mo.) Elkins·Sin n (Cherry Hill, N.J.) Kasco·Efco (Hicksville, N.Y.) Warner·Lambert (Morris Plains, N.J.) Texas Pharmacal (San Antonio, Tex.) Texas Pharmacal (San Antonio, Tex.) Texas Pharmacal (San Antonio, Tex.) Dome (West Haven. Conn.) Schering (Bloomfield, N.J.)
:ij
12-23-71
:ij
Determination of red blood cell volume or mass Diagnostic agent Antibacterial
12-22-71
:ij
Antibacterial
12-22-71
:ij
Anti·inflammatory
12-22-71
:ij
Anti·inflammatory
12-22-71
:ij
Anti·inflammatory
12-22-71
:ij
Anti·inflammatory
1-4-72
:ij
Solely for the adjunctive management for the relief of inflammatory manifestations of acute contact dermatitis
12-22-71
Propoxyphene hydrochloride capsule 65 mg Robenogatope injection (sodium rose Bengal 1131) Servisone tablet (prednisone 5 mg) SDPH lyophilized powder for injection (sodium dithphenylhydantoin USP 100 mg and 250 mg with diluent) Sodium chromate Cr n injection Sodium succinate hexahydrate injection 30% Sodium sulfacetamide ointment Sulfisoxazole tablet 500 mg Texacort cream (hydrocortisone 0.25% and 0.5%) Texacort lotion (hydrocortisone 0.25% and 0.5%) Texacort scalp lotion (hydrocortisone 1%) Tridesilon cream (desonide 0.05%) Valisone topical aerosol (betamethasone valerate NF 9.1 mg equivalent to 7.5 mg betamethasone)
:ij
12-27-71
11-16-71
Vol. NS12, No.4, April 1972
187
Womanpower and Politics The following column was written by Helen Rowland. immediate past president of the auxiliary and was published in the Journal in October 1969_ In this year of political activity and presidential elections. I feel that it is most appropriate.
~
Someone said "Don't underestimate the power of a woman." How true-that is, when we make up our minds to do a job. , What is our role in political activity as members of the Women's Auxiliary? As citizens, it is our privilege and our responsibility to elect local, county, state and national government representatives. But, it is also our obligation to help our elected officials in their lawmaking by taking an intelligent and active interest in legislation and by giving them the benefit of our views and judgment. We must assume the responsibility to tell the true story to others. Stress must be made on "each of us" because, by increasing responsibility, one person at a time, we can defeat or support those legislative measures which are so vital to pharmacy. Our job, as Auxiliary members, is first, to understand the legislation and bills; second, to discuss it with family and friends; third, to write letters to our own state legislators or congressmen when alerted to the need. Appeals should not be made in terms of our interests as pharmacists' wives but in terms of public health and general welfare.
NDA Approvals
I. Keep a directory or file of your local assemblymen and senators and of members of the assembly and senate committees on governmental efficiency and public health to which most of our bills related to pharmacy will be referred. Also do the same for your national congressmen. 2. Keep a file of all information you receive from the pharmaceutical association in your locality, other pharmaceutical groups or from periodicals and newspapers relating to bills affecting pharmacy., 3. Write to the state printing office in your state capital for copies of bills in which you are interested. Give the number and title. The U.S. Government Printing Office can supply similar copies for national legislation. 4. Study the provisions of the bills and develop a point of view. S. Prepare an argument or a series, of arguments for or against each measure. The more factual, the more reasonable and "unselfish" the arguments, the more likely they are to receive consideration. 6. Know your own legislators and congressmen, and whenever possible, make personal contacts with them. 7. Be prepared to write letters (or send telegrams) when called upon for quick action. S. If it is possible, attend committee hearings or appear at the time the bill is being presented on the floor. 9: Interest your friends in the legislation you support or oppose. 10. According to our APhA Auxiliary constitution, we cannot take any political action in the name of the Auxiliary which does not have the approval of APhA. We must follow the general directive of the Association in regard to those bills which we support or oppose in the name of the Auxiliary or where we indicate we are members of the Auxiliary. Don't hesitate to write your elected representatives if you have something to say that you think should be called to their attention. It is the straight-forward letter carrying the appeal of earnestness that commands the interest and respect of members of the state assembly and national elected officials. They never tire of hearing from constituents who have something to contribute to the welfare of the nation. Your representatives know you write to make your opinions heard and that they are your voice in Washington. Helen L Lowe 3105 Silverleaf Drive Austin, TX 78757
1**,
As provided. in /130.33 of the FDA regulations (21 CFR 130.33) notice ha.• been given of the following new drugs for which applications or supplemental 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 approved for distribution b!l applicants but previously marketed btl other firms.
Product
186
Applicant
How Dispensed
Principal Indication
Date Approved
Alcaine solution (proparacaine hydrochloride 0.5%)
Alcon (Ft. Worth, Tex.)
II
Local anesthetic
12-22-71
Ancobon capsules (flucytosine 250 mg and 500 mg)
Hoffman·La Roche (Nutley, N.J.)
II
Anti-infective for use only in the treatment of serious infections caused by susceptible strains of Candida and/or C'ryptococcus
11-26-71
Antiminth oral suspension (pyrantel pamoate ,equivalent to pyrantel 250 mg/5 ml) Catara,se sterile ophthalmic (chymotrypsin NF 300 U)
Pfizer (New York, N.Y.)
II
Anthelmintic
12-30--71
Smith, Miller & Patch (New BrunSWick, N.J.)
II
Enzymatic zonulysis for intracapsular lens extraction
12-28-71
Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION
Product
Applicant
How Dispensed
Principal Indication
Date Approved
Cetacort lotion (hydrocortisone 0.125%,0.25%,0.5% and 1%)
Texas Pharmacal· (San Antonio, Tex.)
ij
Anti·inflammatory
12-22-71
Chromitope sodium injection (sodium chromate Cr")
Squibb (New Brunswick, N.J.)
ij
Determination of red blood cell volume or mass
12-27-71
Cortisone acetate tablet 25 mg
Vitarine (Springfield Gardens, N.Y.) Zenith (Northvale, N.J.)
ij
Glucocorticoid
1-3-72
Cyanocobalamin injection 100 mcg/ml and 1,000 mcg/ml
Medical Chemicals (Melrose Park, III.)
ij
Vitamin
12-14-71
Folic acid injection 1 mg/ml
Gotham (Brooklyn, N.Y.)
ij
Vitamin
1-4-72
Folic acid tablet 1 mg
Danbury Pharmacal (Danbury, Conn.)
:ij
Vitamin
12-23-71
Hydrocortisone cream 0.5% and 1%
Sperti (Ft. Mitchell, Ky.)
:ij
Anti·inflammatory
12-29-71
Isoniazid tablet 100 mg and 300 mg
Dow (Zionsville, Ind.)
:ij
Antituberculosis agent
11-4-71
Lidocaine hydrochloride injection 1/,%,1% and 2%
Invenex (San Francisco, Calif.)
:ij
Anesthetic
12-29-71
Lipo·Hapin injection (in each ml: sodium heparin 1,000, 5,000, 10,000, 20,000 and 40,000 USP units)
Riker (Northridge, Calif.)
:ij
Anticoagulant
11-16-71
Lubricort cream (hydrocortisone 1%)
Texas Pharmacal (San Antonio, Tex.)
:ij
Antl·inflammatory
12-22-71
Lubricort lotion (hydrocortisone 0.25%,0.5% and 1%)
Texas Pharmacar (San Antonio, Tex.)
:ij
Anti·inflammatory
12-27-71
Meperidine hydrochloride injection 25 mg/ml, 50 mg/ml, 75 mg/ml, 100 mg/ml and 100 mg/2 ml
Knoll (Orange, N.J.)
:ij
Narcotic analgesic
12-22-71
Methyltestosterone tablet 10 mg and 25 mg
Lilly (Indianapolis, Ind.)
:ij
Androgen
12-22-71
Potassium chloride injection 10 mEq, 20 mEq, 30 mEq and 40 mEq
Travenol (Morton Grove, III.)
:ij
Electrolyte replenisher
12-22-71
Prednisone tablet 2.5 mg and 5 mg
Barrows Pharmacal (Inwood, N.Y.)
:ij
Glucocorticoid
12-23-71
Prednisone tablet 5 mg
First Texas (Dallas, Tex.)
:ij
Glucocorticoid
12-22-71
Prednisone tablet 5 mg
Zenith (Northvale, N.J.)
:ij
Adrenocortical steroid
11-16-71
Prednisolone tablet 5 mg
First Texas (Dallas, Tex.) Stayner (Berkeley, Calif.) Zenith (Northvale, N.J.) Zenith (Northvale, N.J.) Squibb (New Brunswick, N.J.) Lederle (Pearl River, N.Y.) Rachelle (Long Beach, Calif.)
:ij
Glucocorticoid
12-22-71
:ij
Analgesic
11-30-71
:ij
11-23-71
:ij
Diagnostic agent Glucocorticoid
:ij
Anticonvulsant
12-23-71
Mallinckrodt Nucleur (St. Lou is, Mo.) Elkins·Sin n (Cherry Hill, N.J.) Kasco·Efco (Hicksville, N.Y.) Warner·Lambert (Morris Plains, N.J.) Texas Pharmacal (San Antonio, Tex.) Texas Pharmacal (San Antonio, Tex.) Texas Pharmacal (San Antonio, Tex.) Dome (West Haven. Conn.) Schering (Bloomfield, N.J.)
:ij
12-23-71
:ij
Determination of red blood cell volume or mass Diagnostic agent Antibacterial
12-22-71
:ij
Antibacterial
12-22-71
:ij
Anti·inflammatory
12-22-71
:ij
Anti·inflammatory
12-22-71
:ij
Anti·inflammatory
12-22-71
:ij
Anti·inflammatory
1-4-72
:ij
Solely for the adjunctive management for the relief of inflammatory manifestations of acute contact dermatitis
12-22-71
Propoxyphene hydrochloride capsule 65 mg Robenogatope injection (sodium rose Bengal 1131) Servisone tablet (prednisone 5 mg) SDPH lyophilized powder for injection (sodium dithphenylhydantoin USP 100 mg and 250 mg with diluent) Sodium chromate Cr n injection Sodium succinate hexahydrate injection 30% Sodium sulfacetamide ointment Sulfisoxazole tablet 500 mg Texacort cream (hydrocortisone 0.25% and 0.5%) Texacort lotion (hydrocortisone 0.25% and 0.5%) Texacort scalp lotion (hydrocortisone 1%) Tridesilon cream (desonide 0.05%) Valisone topical aerosol (betamethasone valerate NF 9.1 mg equivalent to 7.5 mg betamethasone)
:ij
12-27-71
11-16-71
Vol. NS12, No.4, April 1972
187