* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Download DEPARTMENT OF HEALTH AND HWAN SE&VICES
Survey
Document related concepts
Psychopharmacology wikipedia , lookup
Neuropharmacology wikipedia , lookup
Pharmacognosy wikipedia , lookup
Drug design wikipedia , lookup
List of off-label promotion pharmaceutical settlements wikipedia , lookup
Drug interaction wikipedia , lookup
Theralizumab wikipedia , lookup
Prescription costs wikipedia , lookup
Pharmacogenomics wikipedia , lookup
Drug discovery wikipedia , lookup
Prescription drug prices in the United States wikipedia , lookup
Compounding wikipedia , lookup
Transcript
DEPARTMENT OF HEALTH AND HWAN SE&VICES FOOD AND DRUG ADLL~INISTRATION [DOCKET NO. 76N-0052] COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE DECISION c-y AGENCY: Food ACT ION : Notice. ON DOSAGE OF PSEUDOEPHEDRINE PREPARATIONS and Drug SUMIVIARY: The Fooil until orai furtner nasai an6 Drug notice the aecongestant pseuaoepnedrine are dosage Interval. dosage interval from every 6 nours three manufacturers every aata 4 to reflecting dosage of Antiasthmatic date uelng stayed pseudoepnedrine OTC Coid, Drug 1981, changing to reduce preparations in will OTC revised the 4 hours Aiiergy, interval the the 50 mg froti - and shouici be laDeling maximum daiiy proposed 2roncnodllator, nor. be stayed hourly to a petition revised to Cougn, Proaucts date aosage requirea aecision FDA's new pharmacokinetic nourly However, extending of witll response who submitted is manufacturers (my) every in the (FDA) containing to comply 60 miillgrams agency's May i, products The effective 6 hours. for oy wnich drug to show that the monograpn effective is Administration required hourly safety Administration. and will and aecome DATE: Tne effective inaximum aaily required untli date uosage requirea relaoeling 198i. The effective is Nay 1, relabeling further ior for notice, tne hourly pending dosage review of for tne date interval is for stayed new data, FOR FURTHER INFORMATION CONTACT: \i\lilli.am E. Gilbertson, Bureau Food of Drugs and Drug (HFD-SiO), Administration 5600 Fishers I Lane, Rockville, MD 20857, 301-443-4560. SUPPLBMENTARY INFO.WATION: September that the aaily 30, 1980 availaole dosage drug OTC use as an oral oy the Aavrsory explained tnat products nasal data of significant side and that appropriate. not tne support Panel Panel's effects a 240-mg the containing decongestant that the proposed could 360-mg Cough, concluded from that, for recommendea Allergy, after monograpn maximum dally maximum The notice agency result decision had been Proaucts. to tne pseudoepnedrine on OTC Cold, suomitted The agency FEDERAL REGISTER of FDA announced and Antiasthmatic pubiication dosage uid Review Bronchodilator, the (45 FR 64709), data for In the dosage under the suggest 360-mg that daily LS more tne procedures - established labeied in with - 21 CFR 330.13(b)(2), the be relabeled 3 nigner witn dosage specified pseudoephedrine limitations lower products would dosage be required limitations to by January isal. 30, In the the FEDERAL REGiST5R of agency granted the 1381, two petitions effective limitatsons December date that for had oeen 19, 1980 and extended compliance set forth until with in the (45 r"R 8367l.), the May 1, revised September dosage 30, 1980 notice. On Aprii Corp., 2, the 60-mg petitioners every Hay 1, pharmacokinetlc instead requested they suomitted for decision. was provided (A copy (formeriy Fooa and Drug MD of 20857. and a tnem to petition the Administration, of weie issued, products the of as the to enable pseudoephedrine LPIanagement Branch Rockville, thereto The an extension which respect which interval data labeiing Lane, a dosage and safety revise Fishers of Co. 6 hours. time thereafter (%?A-30ti), to every The petitioners with Schering tine decision such time office) of until reasonaole Dockets part date a decision final from effective evaluatea, the that interval adoption 6 hours. 198i, a petition and Burroughs-Wellcome of dosage sought 4 to agency's Co., reconsideration extends tne FDA received The Dow Cnemical requesting the 1981, is Rearing to reflect on file the in Clerk's -Rm. 4-62, 5600 - 4 The petitioners based new pharmacokinetic aione and in malor determinant pH of tne dosing more combination of belleve rsflectrve dosage of every data with the every of the other drugs, of the data 4 to 6 hours have is that 6 hours is blood established both shown that the The that a flexible permissible and is levels in the is excreted. demonstrate achievaDle belief pseudoephedrine pseudoephedrine that of on their on pseudoephedrine, naif-life in whicn schedule request and safety urine petltloners their the than the September fixed 30, 1930 notice. FDA nas considered good and sufficient until further the revised the new data products notlce are labeled 6 hours until the of reason the dosage every agency's a 24-hour in the excess of 1931 60 mg every In the also period from 30, 240 mg of state reauce 360 to staying 6 hours for until pseudoephedrine 4 hours or 60 mg OTC drug on the that date interim, on the aosage for effective of a decision 6- nour to provided 60 mg every issues decision September May i, De permitted Tne petitioners and has conciudeb has been reviewed. will 4- to request interval eitner agency an every this market appropriateness interval. that the pseudoephedrine support maximum aduit 240 mg. 1930 notlce they that the, dosage The agency a daily auring deelded dosage may i3e associated in -with L significant side Therefore, benefit. reflecting labeling aaults will forth effects for tie and corresponding not in be stayea the without safety Septem ber reasons, m axim um daily m axim um dally and will therapeutic additional requirea OTC dosage of OTC aosages becom e effective 30 and Decem ber revised L9, M ay I, 1980 240 m g for for children 1981 notices, as set