NDA Approvals

NDA APPROVALS As provided in § 130.33 of the FDA regulations (21 CFR 130.33). notice has been given of the following new drugs for which applications or sUPcflemental applications for subse~uent labeling changes, have been approved. This list is published for information of pharmacists but it is not intende to advise on the use of the pro uets. Drugs listed may include some now approved for distribution by applications but previously marketed by other firms. active ingredients

applicant

trade name

how dispensed

principal indication

date approved

Oratrol

Alcon Laboratories

Oichlorphenamide 50 mg per tablet

1l

Carbonic anhydrase inhibitor

4/3/67

Triavll

Merck Sharp & Oohme

Perphenazine 2 mg Amitriptyline hydrochloride 10 mg and 25 mg Perphenazine 4 mg Amitriptyline hydrochloride 10 mg and 25 mg

1l

Tranquilizer-antidepressant

4/4/67

Vontrol Tablet

Smith Kline & French

Oiphenidol 25 mg per tablet, as the hydrochloride

1l

Antiemetic

4/5/67

Vontrol Injection

Smith Kline & French

Oiphenidol 20 mg per ml, as the hydrochloride

1l

Antiemetic

4/5/67

Vontrol Suspension

Smith Kline & French

Oiphenidol 20 mg per 5 ml, as the pamoate

1l

Antiemetic

4/5/67

Vontrol Suppository

Smith Kline & French

Oiphenidol 25 mg and -50 mg

1l

Antiemetic

4/5/67

"Kenacort" Diacetate Syrup

E.R. Squibb & Sons

Triamcinolone diacetate 5 mg per 5 cc

1l

Anti-inflammatory

4/6/67

"Kenacort" Tablets

E;R. Squibb & Sons

Triamcinolone 1, 2, 4, or 8 mg per tablet

1l

Anti-inflammatory

4/6/67

Mintezol

Merck Sharp & Oohme

Thiabendazole

1l

Anthelmintic-enterobiasis, intestinal parasitoses, strongyloidiasis

4/7/67

Dipyrone Injection 5 cc Ampules 30 cc Vials

Gotham Pharmaceutical

Each 5 cc ampUle: Oipyrone (Aminopyrine derivative) 2.5 gm water for injection q.s. Each cc in the 30 vial: Oipyrone (Aminopyrine derivative) 0.5 gm Benzyl alcohol; 1.5%; water for in. jection q.S.

1l

Antipyretic

4/10/67

Haldol Tablets

McNeil Laboratories

Haloperidol 0.5,1 mg and 2 mg tablets

1l

Tranquilizer

4/12/67

Haldol Concentrate

McNeil Laboratories

Haloperidol, 2 mg per cc

1l

Tranquilizer

4/12/67

Choloxln

Baxter Laboratories

Sodium dextrothyroxine, 2 mg and 4 mg tablets

1l

Treatment of hypercholesterolemia

4/14/67

Pentaerythritol Tetranltrate

Philips Roxane La boratories

Pentaerythritol tetranitrate, 10 mg

1l

For management of angina pectoris

4/14/67

Sintrom

Geigy Chemical

Acenocoumarol,4 mg tablets

1l

Anticoagulant

4/14/67

Mintezol

Merck Sharp & Oohme

Th ia bendazole

1l

Anthelmintic-enterobiasis, intestinal parasitoses, strongyloidiasis

4/21/67

Temp

Table Rock Laboratories

Oipyrone, 500 mg tablets

1l

Antipyretic

4/24/67

Temp

Table Rock Laboratories

Oipyrone, 250 mg/cc pediatric drops

1l

Antipyretic

4/24/67

Temp

Table Rock Laboratories

Oipyrone, 500 mg/5cc (teaspoonful)

1l

Antipyretic

4/24/67

Ovulen

G.O. Searle

Ethynodiol diacetate 1.0 mg, Mestranol 0.1 mg tablet

1l

Oral contraceptive

4/24/67

Pu rified Corticotropin-Gel

Wilson Laboratories

Each cc contains 40 USP Cortico· tropin units; 80 USP Corticotropin units

1l

Anterior pituitary hormone

4/25/67

New Colgate Dental Cream Gardol plus MFP

Colgate· Palmolive

Sodium monofluorophosphate, Sodium N·lauroyl sarcosinate

OTC

Anticaries dentifrice

5/2/67

Stero-Darvon with ASA

Eli Lilly

Paramethasone acetate pro· poxyphene hydrochloride aspirin

1l

Anti-infla m matory analgesic in rheu· matoid arthritis

5/3/67

Potassium Chloride USP

Stanley Drug Products

Potassium chloride 5.0 grains and 1.0 gram

1l

Electrolyte replenisher for the treatment of potassium deficiency

5/4/67

504

Journal of the AMERICAN PHARMACEUTICAL ASSOCIATION

trade name Novaldin

applicant Winthrop Products

active ingredients Dipyrone 50% (weight/volume)

how dispensed

II

principal indication

date approved

Antipyretic

5/15/67

Vaginal Douche

5/10/67

II

Tranquilizer

5/29/67

II

Hormone

6/6/67

Chloroquine phosphate 500 mg/ta blet, Primiquine phosphate 79 mg/ta blet

II

Antimalarial

6/6/67

Ortho Pharmaceutical

Chlordantoin 1% Benzalkonium chloride 0.5%

II

Antifungal agent

6/7/67

Sporostacin Solution

Ortho Pharmaceutical

Chlordantoin 1% Benzalkonium chloride 0.5%

Sporostacin Cream

Ortho Pharmaceutical

Chlordantoin 1% Benzalkoniumchloride 0.5%

II II

Antifungal agent Antifungal agent

6/7/67 6/7/67

loprep

Johnson and Johnson

Nonoxynol 4, Nonoxynol 15iodine complex, 5.5% W/W; Nonoxynol30- approx.10% W/W (surfactant) 1% available Iodine

OTC

Topical antiseptic

6/8/67

10% Dextrose Injection in Plastic Container

Baxter Labs

10% Dextrose injection

II

Replenisher of body fluid and nutrient

6/9/67

5% Dextrose and 0.9% Sodium Chloride Injection in Plastic Container

Baxter Labs

5% Dextrose and 0.9% Sodium chloride injection

II

Replenisher of body fluid, nutrient and electrolyte

6/9/67

Norlestrin-l mg

Parke· Davis

Norethindrone acetate 1 mg Ethinyl estradiol 0.05 mg

II

Oral contraceptive

Stero-Darvon with ASA

Eli Lilly

Propoxyphene HCI 32 mg Paramethasone acetate 0.25 mg Aspirin 500 mg

II

Vespre

Ortho Pharmaceutical

Dequalinium acetate 0.4% Benzalkonium chloride 4.0%

OTC

Solacen

Wallace Pharmaceuticals

Tybamate 250 mg

Compressed Tablet Halodrin

Upjohn

Fluoxymesterone, 1 mg Ethinyl estradiol, 0.02 mg

Aralen PhosphatePrimaquine Phosphate

Winthrop Laboratories

Sporostacin Lotion

6/14/67

Anti·infla mmatory analgesic 6/16/67

Taractan Concentrate

Hoffmann·La Roche

Chlorprothixene 100 mg per 5 cc

II

Tranquilizer

6/19/67

Norquen

Syntex Labs

Mestranol 0.08 mg Norethindrone 2 mg

II

Oral contraceptive

6/28/67

Jectofer

Astra Pharmaceutical Products

Each cc contains Iron·sorbitol citric acid complex, dextrin stabilized 310 mg

II

Hematinic

6/28/67

Hiprex

Riker Labs

Methenamine hippurate

II

Urinary antiseptic

7/5/67

Quaalude

William H. Rorer

Methaqualone, 150 and 300 mg tablets

II

Sedative hypnotic

7/7 /67

Aquatag

S.J. Tutag

Benzthiazide 25 and 50 mg

II

Diuretic

7/14/67

Hygroton

Geigy Pharmaceuticals

Chlorthalidone 50 and 100 mg per tablet

II

Diuretic

7/14/67

drugs for veterinary use Delta-Co rtef

Upjohn

Prednisolone

Cuprate

Burns Pharmaceuticals

Copper (as copper glycinate) 60 mg Polyvinylpyrrolidone 5 mg Sodium carboxymethyl·cellulose 5 mg Sodium citrate 6 mg Methylparaben* 0.08% Propylparaben* 0.02%

OTC

II

Anti-infla m matory

3/22/67

A sterile suspension of copper for the pre· vention and treat· ment of molybdenum poisoning and copper deficiency in cattle

3/29/67

Terramycin Potentiated Pet Tablets

Chas. Pfizer

Oxytetracycline hydrochloride 200 mg plus pentanetetracarboxylic acid (oxa·acid) 200 mg of 3-oxa-1,2,4,5

II

Management of bacterial infections

3/31/67

Butazolidin

Jensen·Salsbery Laboratories

Phenylbutazone

II

A non-hormonal anti· inflammatory agent with significant an· algesic and antipyretic properties

4/17/67

Vetisulid

Ciba Pharmaceutical

Sulfachlorpyridazine 250 mg

II

Antibacterial (for dogs only)

4/18/67

Llncocin

Upjohn

Lincomycin hydrochloride monohydrate

II

Antibacterial (for cats and dogs only)

5/24/67

Suldixine Tablets

Haver·Lockhart Labs

Sulfadimethoxine 2 gr

II

Antibacterial (for dogs)

6/13/67

Gallimycin-36

AMDAL

Erythromycin 50 mg/cc

Mastitis in cattle

7/11/67

OTC

*as preservatives.

Vol. NS7, No, 9, September 1967

505