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[DESI 10761; DoCket No. FDC-D-560: ND.t\ 10-761J DOW CtlEMICAL CO. Certain Antiseborrheic Drugs Containing Cadmium Sulfide for Topical Use; Notice of Withdrawal of Approval of New Drug Application A notice was published in the FEDERAL REGISTER of January 3D, 1973 (38 FR 2777) I extending to the Dow Chemical Co., P.O. Box 10, Zlonsvillc, Ind. 46077 and to any interested person, an oppor- tun.1ty for hearing on the proposal of the Commissioner of Food and DrUgS to issue an order under section 505(e) of the Federal Food. Drug, and Cosmetic Act withdrawing approval of NDA 10-761 for Capsebon Suspension containing cadmium sulfide. 1'he basis of the pro- POSed action was the lack of substantial evidence that the drug is effective for its labeled indications. Allldent1cal, rel:l.ted, or Bimllar prooM nets, not the subj ect of an approved new drug application, are covered by the new drug app.l1cation reviewed and are sub- Ject to this notice. See 21 CPR 130.40 (37 m 23185, Oct. 31. 1972). Any person who wtshes to determine whether a specific product is covered by this notice should write to the Food and Drug Admin.1stra- t1oD, Bureau of Drugs, Office of Com- pliance (BD-300) , 5600 Fishers Lane, Rockvl1Ie, Md. 20852. Neither the holder of the application nor any other person flIed a written ap- pearance of election wi thin the 30 days provided. by said notice. The failure to file such 1m. appearance constitutes elec- tion by such persaI18 not to avaH them- selves of an opportunity for hearing. The Commissioner of Food and Drugs PUl'suant to provisions of the Federal Food. Drug, and cosmetic Act (sec. 50S, 52 Stat. 1053, as amended; 21 U.S.C. 355), and the Ad.m1n1stra.tive Procedure Act (5 V.S.C. 554). and under authority dele- gated to l1im \21 em 2.120). finds that an the basis of new informa.tion before him with regard to the drug, evaluated together with the evidence available to him when the application waS approved. there is a lack of substantia.l evidence that the drug will have the effect it pur- ports or is represented to have under the conditions of use prescribed, recom- mended, or suggested m the labeling thereof. Therefore. pursuant to the foregoIng .Jlnd.ing, approval of new drug application ~iNO': 18-761 and all amendments and SUP- plements; thereto is withdrawn etrectirve on May 2, 1973. . . ' ShIpment in interstate comm~e of the above~listed drug product or of any identical, rela.tedt,.G't' simila.r product, not the subject o:r:_,~p:rovedl new drug aP- plication, Is linfek>rtb Wllawful. Dated i\PrU 24.. 1973. Sw D. FINE, Associate Commissioner lor Compliance. [m Doc.73-8522 FlIed 6-1-73;8:45 am) NOTICES IDl!'.SI 12178; DocUt No. FDC-D-543; NDA 12-1761 HYDROXYCHLOROQUINE SULFATE IN COMBIN1> TION WrTH ASPIRIN Notice of Withdrawal of Approval of New Drug Application On December 21, 1912, there was pub- lished in the FEDERAL REGISTER (37 FR 28525) a notice of opportunity for hear- ing (DESI 12176) in which the Commis- sioner of Food and Drugs proposed to issue an order under section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) withdrawing ap- proval of the new drog application for the following drug: NDA 12-176; PIanolar Tablets contain- ing hydrox)'chloroquine sulfate and as- pirin; formerly marketed by Winthrop Laboratories, 90 Park Avenue. New York, N.Y. 10016. The basis of the proposed withdrawal of approval was the lack of substantial evidence that thIs fixed combination drug will have the effect that it purports or is represented to have under the conditions of use prescribed. recommended, or sug- gested in the labeling. Neither Winthrop Laboratories nor any other interested person has filed a ~Tit- ten appearance of electIon as provided by said notice. The faHure to fl.Ie such an appearance constitutes an election by such 'Persons. not to avail themselves of the OPportunity for a hearing. All Identical , related. or similar prod- ucts, not the subject of an approved new drug application, are covered by the new drug application reviewed and are sub~ ject to this notice. See 2-1 CFR 130.40 (37 FR 23185, Oct. 31, 1972). Any person who wishes to determine whether a s.pe- cific product is covered by this notice should write to the Food and Drug Ad4 ministration, Bureau of Drugs, Office of Compliance (B0-300), 5600 Fishers Lane. Rockville, Md. 20852. The Commissioner of Food and Drugs, pursuant to the prOvisions of the Fed- eral Food, Drug, and Cosmetic Act (sec. 505,52 Stat. 1053, as amended; 21 U.S.C. 355), and the Administrative Procedure Act (5 U.S.C. 554), and under authorIty delegated to him \21 CPR 2.120). finds that on the basis of new information before him with respect to the drug, evalua.t.ed t()gethe-r 'with the evidence avauable to him when the application was approved, there is a lack of .substan- tial evidence that the drug will have the effects it purports or 13 yepresented to have WIder the conditions of USI$1:P~ scribed, recOIJ1Dlended, or sugg~~d in the labeling thereof. Therefo5..' pursuant to the foregoing findings,'l1IlJf6.val of the above new drug application -and all amendments n.nd supplements flJ)PI'yiBg thereto is with:' drawn, effective 011' May 2, 1973. Ship- ment in interstate commerce of the above-listed drug product or of B.IlY identica.l, related, or simUar product, not 10829 the subject of an approved new drug application, is henceforth unlawful'. Dated Aprll 24, 1973. SAM D. FINE, Associate Commissioner jor Compliance. {FR Doc.73-8520 Filed 5-1-73:8:45l\TCl) (FAP 2A2791J PHARMACHEM CORP. Notice of Withdrawal of Petition for Food Additives Pursuant to prOvisions of the Federal Food, Drug, and Cosmetic Act (sec. 409 (b). 72 Stat. 1786.; 21 U.S.C. 348 (b) ) , the~ folIowing noti~e. is: iSsued: In accordant:e with A 121.52 . with- drawal of petitto'fls. without prejUdice of the procedural food: additive regulations (21 CFR 121.52')', Pharmachem Corp" 719 Stefko Boulevard, Bethlehem, Po.. 18018, has withdrawn its petition .~FIIP 2A2791), notice of which was pUblished in the FEDERAL RECISTER of June 13 1:972 (37 FR 11739) , proposing the issu~ce at a food additive regulation G21 CFR part 121) to prOvide for the sMe Use of hIgh moleculllr weight dextran mr an anti- staling agent, preservative, filler, and bulking agent in foods. Dated April 24. 1973. VIRGIL O. WODICKA, Director, BUTeau of Foods. &.~ ~oc.70-8523 FUed 5-1-73;8;45 any' ~.' ..'I':'.'~ ~I' ~~ . CGR~3a00121 ",', WESTERN RY PROOUCTS Notice of Filing t.i.tiiOn. for Affirmation of , ~tatus pursunnt to pro siclhs of the Federal Food, Drug. and Cosmel.1c Act (sees. 201 (s), 409. 701\a), 52 Stat.~ 72 Stat. 1784- 1786: 21 U.S.C. 321(5), 348 371(all and the regulations for affirmation of GRAS status (21 CFR 121.40), published in the FEDERAL REGISTER of December 2, 1972 (37 FR 25105), notice 1:s given that a petition lGRASP 3G0012) has been filed by Western D8Iiry Products, DLwsion of Chelsea Industries. Inc., 118 World Trade Cent.er, San Francisco, Calif. 94111. and placed on pUbl1c display at the oDice of the Hearing Clerk, Food a.nd Drug Ad- ministration, proposiDg,- all:-ma:tion that partia.lly hydrolyzeQ pF0telllSl ere' gen- erally recognized as safe (GRAS,). for use as toads. Interested persons may, on or before July 2, 1973, review. the petition and/or file comments (prefernbly in' qUintupl1'- . cate) with the Hearing Clerk, Depart- ment o~ He3llth. Education, and Welfare, Food Qt'd. Drug AdInJDi::;tration, room 6-88, dtiQo Fisher Lane, Rockville, Md. 2Q852. Comments sh9uId include any available i'n1ormation that would be belpful in determining whether the sub- .stance is, or Is not, generalfy recognIzed as safe. A copy of the petition and re- ~uu\. No. 84-pt. 1---6 FEDERAL REGISTER, VOL. 38, NO. 84-WEDNESDAY. MAY 2, 1973