first edition (1980) of the Orange Book - FDA Law Blog

More documents

Recommendations

Info

To assist the user in relating the name of the firm 00 the productlabel (the marketer) to the awlicatioo holder identified on the List inorder to determine the product's therapeutic equivalence evaluation, thefollowing should be noted. If the marketer is the awlicatioo holder, theawlicatioo holder identified 00 the List is the same as the name of thefirm 00 the product label. If the marketer is related corporately (e.g., asubsidiary) to the awlicatioo holder, that relatiooship is noted 00 theList. If the agency is unaware of a corporate relatiooship between themarketer and the awlicatioo holder, the List identifies ooly the awlicatiooholder. In this case, the List identifies the drug product (which isthe subject of a single awlicatioo) by its generic name if the product isavailable from more than one marketer, and by its brand name if the productis available from ooe marketer ooly.5. Any product on the List is subject at all times to regulatory action.From time to time awroved products may be found to be in violatioo ofme or nore requirements of the Federal Food, Drug, and Cosmetic Act. Insuch circumstances, the agency will oommence awropriate enforcement actionto remove the violative product from the market by voluntary recall orseizure. If the problem leading to the violatioo is continuing, so thatthere exists a risk of future noncomplying prod~cts entering the market, FDAwill undertake steps to eliminate that risk, e.g., by court injunctioo,witl'rlrawal of the awroval of the marketing awlicatioo, or revocatioo ofthe antibiotic certification. Where the violatioo is corrected by removalof the particular batch of the product from the market, no need exists toexclude the product from this List; the awroval continues and other batchesare not affected. Where additiooal preventive actioo is indicated, theagency will utilize awropriate legal procedures to keep the product off themarket. Such regulatory actioo, however, is independent of the inclusioo ofprodu::ts in the List. The sole criterioo for inclusioo of marketed productsin the List is their being the Subject of an awroved awlicatioo. Marketedprodu::ts will not be removed from the List until completion of FDA proceedingsto witl'rlraw awroval of the product under sectioos 505 or 507, asawlicable. FDA believes that retentioo of a violative product 00 the Listwill not have any significant adverse health consequences because otherlegal tools are available to the agency to prevent actual marketing ofviolative products.It should also be noted that when there is a change in the informatioocontained in FDA files cooceming a multiple source drug product that is onthe List, there exists the potential that the drug product will no longermeet the criteria for therapeutic equivalence. as initially evaluated. Inthis instance, FDA will re-evaluate the drug's therapeutic equivalency byaWlying the current informatioo to the criteria for therapeutic equivalence.If the re-evaluatioo reveals that the listed therapeutic equivalenceevaluatioo is· no looger accurate, the evaluation will be revisedaccordingly.I - 8
6. Patent status of drug products not considered.The patent laws have no bearing 00 the enforcement of the Federal Food,Dr ug, and Cosnetic Act, and the agency does not consider these laws whenreviewing new drug awlicatioos and making drug product awroval decisions.Thus, if a firm subni ts a drug application for a drug that is patented, FDAreviews the awlicatioo without oonsidering the patent issue. If theawlication is approvable, the existence of a patent would not affect theagency's decisioo Do grant awroval for marketing.F. CODES AND SPECIFIC OOLICIES FDR THERAPEIJ'l'IC EYJU:rvAI.EN:E EVALUATIONSThe coding system is ronstructed Do allCM users to determine quicklywhether the agency has evaluated a particular approved product as therapeuticallyequivalent to other pharmaceutically equivalent products. Thecoding system is also intended Do provide specific information on the basisfor FDA's evaluatioos.There are ~ classification categories into whichall of the multisource drugs have been placed, as follows:A - Drug products that FDA considers Do be therapeutically equivalentbo other pharmaceutically equivalent products.B - Drug products that FDA does not at this time oonsider to be therapeuticallyequivalent Do other pharmaceutically equivalent products.A two-letter code is used in the List. The first letter is the basicclassification ("A" or "B") Do which an individual drug product has beenassigned. The second letter in the code designates a more specific reasonfor placing the individual product in that category. The· codes areexplained in this section of the Preface. Indi vidual drug products havebeen evaluated as therapeutically equivalent in accordance with the definitionsand policies outlined below.A - Drug products that are considered to be therapeutically equivalentto other pharmaceutically equivalent products.Drug products designated with an "A" code fall under one of twomain policies: (1) For those active ingredients for which no bioequivalenceissue is known or suspected, the therapeutic equivalence ofpharmaceutically equivalent products is presumed, so loog as theproducts are manufactured in accordance with Current Good ManufacturingPractice regulations and meet the other requirements of their approvedawlications: (2) For those drug products rontaining active ingredientswhich have been identified by FDA as having actual or potentialbioequivalence problems (21 CFR 320.22 or 42 FR 1648, January 7, 1977),I - 9\
Page 5: RXD AND DRUG ACMINISTRATIONAPProVED
Page 9: approved application, a list of app
Page 12 and 13: products that have been approved" i
Page 16 and 17: an evaluatien of therapeutic equiva
Page 18 and 19: ioavailability data is required for
Page 20 and 21: B - Drug products that FDA does not
Page 22 and 23: and the rate of absorption.pharmace
Page 24 and 25: 4. Erythromycin stearate Tablets -
Page 27 and 28: II. LISTINGSA. FORMAT GUIDEThis p..
Page 29 and 30: CURRENT STATUS - POSSIBLY EFFECTIVE
Page 31 and 32: DRUG ProDUCT EKAMPLESSingle Ingredi
Page 33 and 34: APPROVED PRESCRIPTION DRUG PRODUCTS
Page 55 and 56: j./APPROVED PRESCRIPTION DRUG PRODU
Page 65 and 66:
-,----APPROVED PRESCRIPTION DRUG PR
Page 67 and 68:
APPROVED PRESCRI~TIOHDRUG PRODUCTSD
Page 69 and 70:
APPROVED PRESCRIPTION DRUG PRODUCTS
Page 71 and 72:
Page 73 and 74:
Page 75 and 76:
Page 77 and 78:
DIMENHYDlHNATEAPPROVED PRESCRIPTION
Page 79 and 80:
Page 81 and 82:
------"".,APPROVED PRESCRIPTION DRU
Page 83 and 84:
Page 85 and 86:
Page 87 and 88:
Page 89 and 90:
Page 91 and 92:
APPROVED ¥RESCRIPTION DRUG PRODUCT
Page 93 and 94:
Page 95 and 96:
'''"APPROVED PRESCRIPTION DRUG PROD
Page 97 and 98:
----..//APPROVED PRESCRIPTION DRUG
Page 99 and 100:
Page 101 and 102:
Page 103 and 104:
Page 105 and 106:
Page 107 and 108:
Page 109 and 110:
Page 111 and 112:
Page 113 and 114:
Page 115 and 116:
Page 117 and 118:
Page 119 and 120:
Page 121 and 122:
Page 123 and 124:
Page 125 and 126:
"~''''''-- .APPROVED PRESCRIPTION D
Page 127 and 128:
Page 129 and 130:
Page 131 and 132:
Page 133 and 134:
Page 135 and 136:
Page 137 and 138:
Page 139 and 140:
Page 141 and 142:
Page 143 and 144:
Page 145 and 146:
Page 147 and 148:
Page 149 and 150:
Page 151 and 152:
Page 153 and 154:
Page 155 and 156:
Page 157 and 158:
Page 159 and 160:
Page 161 and 162:
Page 163 and 164:
Page 165 and 166:
Page 167 and 168:
Page 169 and 170:
Page 171 and 172:
Page 173 and 174:
Page 175 and 176:
Page 177 and 178:
Page 179 and 180:
Page 181 and 182:
Page 183 and 184:
Page 185 and 186:
Page 187 and 188:
Page 189 and 190:
PERCORTEN PIVALATE, DESOXYCORTICOST
Page 191 and 192:
Page 193 and 194:
Page 195:
oAPPROVED PRESCRIPTION DRUG PRODUCT
Page 198 and 199:
Page 200 and 201:
Page 202 and 203:
Page 204 and 205:
Page 206 and 207:
Page 208 and 209:
Page 210 and 211:
Page 212 and 213:
Page 214 and 215:
Page 216 and 217:
Page 218 and 219:
Page 220 and 221:
Page 222 and 223:
Page 224 and 225:
APPROVED PRESCRIPTIOH DRUG PRODUCTS
Page 226 and 227:
Page 228 and 229:
Page 230 and 231:
Page 232 and 233:
Page 234 and 235:
Page 237 and 238:
Page 239 and 240:
Page 241 and 242:
Page 243:
Page 246 and 247:
PRESCRIPTION DRUG PRODUCTS DEEMED A
Page 248 and 249:
Page 250 and 251:
show all

first edition (1980) of the Orange Book - FDA Law Blog

Create successful ePaper yourself

Delete template?

Save as template?