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

More documents

Recommendations

Info

B - Drug products that FDA does not at this time consider to be therapeuticallyequivalent to other pharmaceutically equivalent products.Certain multisource drugs awearing on the List have beenclassified with .a "B" code for a variety of reasons. Those drugs thathave been identified ~ the agency as having potential or actual bioinequivalenceproblems and for which adequate studies denmstrating thebioequivalence of the particular product have not been submitted to FDAare classified in the "B" category. A "B" evaluatioo generally is aresult of known or potential problems with the specific dosage form forthose active ingredients for which no bioinequivalence problem has beenidentified by the agency. In additim, there are currently a fewproducts for which the standards are inadequate or for which FDA hasinsufficient informatim at the present time to determine if they are,ther apeu ticall y equivalent.The specific coding definitions and };X>licies for the "B" sub-codesare as folloos:BeControlled Release Tablets, Capsules, and InjectablesThese dosage forms are subject to bioavailability andbioequivalence differences, primarily because differentfirms developing controlled release products for the sameactive ingredient rarely employ the same approach toformulating their controlled release products. FDA,therefore, does not evaluate different controlled releasedosage forms containing the same active ingredient inequal strength as bioequi valent unless equi valencebetween individual products has been specifically dernoostratedthrough appropriate bioequivalence studies.Controlled release products for which bioequivalence dataare available have been coded AB.BDActive Ingredient and/or Dosage Forms with DocumentedBioinequivalence ProblemsThe BD code denotes products containing activeingredlents wi th kno.vn bioinequi valence problems, and forwhich adequate studies have not been sutmitted to FDAdemonstrating the bioequivalence of the drug products.Where such studies are available, the product has beencoded AB.I - 14
BEEnteric Coated Oral Dosage FormsDrug products in enter ic coated dosage forms containingthe same active ingredients are subject to significantdifferences in absorptioo. In general, such productscannot be coosidered pharmaceutically equivalent becausethey do rot necessar ily meet similar standards, and fewmanufacturers of enteric coated products have studied thepharmacokinetics of their products. Unless otherwisespecifically noted, the agency does not coosider differententer ic coated products containing the same activeingredients as bioequivalent. If studies have demoostratedthe bioequiva1ence of enteric coated products,such prodocts are coded AB.BNProducts in Aerosol-Nebulizer Drug Delivery SystemsThis code only applies to drug solutioos or pcMders thatare marketed ooly as a component of, or are only compatiblewith, a specific drug delivery system. There may besignificant differences, for example, in the dose of drugand particle size delivered by different products.Therefore, such products are not regarded as pharmaceuticallyequivalent.BP Active Ingredients and Dosage Forms with PotentialBioequivalence IssuesFDA's bioequi valence regulations (21 em 320.22) containcr iter ia and procedures for determining whether aspecific active ingredient in a specific dosage form hasa potential for poor absorptioo. It is FDA's policy toconsider an ingredient meeting these criteria as having apotential bioinequivalence problem even in the absence ofpositive data deIOCllstrating inequivalence. Pharmaceuticallyequivalent prodocts containing these ingredients inoral dosage forms are included in this category pendingresolutioo of their bioequivalence or lack of it.Injectable suspensioos containing an active ingredientsuspended in an aqueous or oleaginous vehicle have alsobeen included in this sub-category. Injectable suspensioosare subject to bioinequivalence problems becausedifferences in particle size, polymorphic structure ofthe suspended active ingredient, or the suspensionformulatioo can significantly affect the rate of releaseI - 15
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 14 and 15: To assist the user in relating the
Page 16 and 17: an evaluatien of therapeutic equiva
Page 18 and 19: ioavailability data is required for
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 71 and 72:
APPROVED PRESCRIPTION DRUG PRODUCTS
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?