Biopharmaceutical Products in the U.S. and European Markets, Regulatory/Status Index

Biopharmaceutical Products in the U.S. and European Markets, 6th Edition

Regulatory/Status Index

Biopharmaceutical Products in the U.S. and European Markets

505(b)(2) generic drug approvals -- 165; 166; 186; 255; 617; 618;
accelerated approval (based on surrogate endpoints) (FDAapproved) -- 117; 118; 118; 119; 126; 128; 129; 163; 163; 203; 203; 211; 212; 212; 220; 228; 235; 257; 264; 264; 306; 477; 488; 650; 768; 790; 933; 945;
application expected (2007-8) in U.S. -- 102; 106; 112; 113; 122; 124; 125; 173; 223; 224; 233; 242; 246; 271; 273; 301; 417; 475; 481; 541; 566; 602; 610; 627; 628; 769; 911; 938; 947;
application expected (2007/8) in Europe (EU or European countries) -- 112; 122; 131; 185; 215; 223; 233; 627; 914;
application pending, EU or European countries -- 106; 113; 129; 134; 135; 139; 140; 237; 266; 452; 603; 619; 763; 945;
application rejected, EU -- 173; 207; 274;
application withdrawn in EU -- 112; 137; 236; 251; 258; 523; 633;
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved) -- 136; 406; 410; 411; 412; 419; 421; 425; 426; 448; 449; 450; 471; 509; 514; 517; 518; 525; 526; 533; 536; 544; 548; 549; 550; 551; 552; 553; 554; 557; 558; 559; 563; 567; 609; 702; 731; 733; 752; 753; 767; 797; 806; 916; 917;
approval pending, U.S. -- 142; 153; 185; 215; 225; 244; 249; 260; 261; 266; 315; 445; 446; 490; 530; 540; 656; 714; 741; 742; 902; 903; 945; 948;
approval rejected in U.S. -- 141; 162; 235;
approvals , FDA, as biologic -- 114; 115; 116; 117; 119; 126; 128; 129; 133; 136; 143; 144; 145; 146; 147; 148; 149; 150; 151; 152; 158; 159; 163; 165; 166; 169; 174; 175; 179; 184; 186; 187; 188; 189; 190; 191; 203; 204; 205; 206; 208; 209; 210; 211; 212; 213; 214; 216; 218; 220; 221; 222; 226; 227; 230; 238; 239; 240; 243; 245; 255; 264; 265; 267; 268; 269; 270; 275; 276; 303; 304; 305; 306; 307; 310; 311; 312; 313; 314; 402; 403; 404; 405; 406; 408; 409; 410; 411; 412; 414; 419; 420; 421; 422; 423; 424; 425; 426; 427; 430; 431; 433; 434; 435; 436; 437; 441; 443; 447; 448; 449; 450; 451; 454; 455; 456; 457; 458; 459; 460; 463; 464; 466; 469; 471; 472; 477; 478; 479; 480; 488; 489; 491; 492; 493; 496; 498; 499; 500; 502; 503; 504; 507; 508; 509; 510; 511; 513; 514; 515; 517; 518; 519; 521; 522; 523; 524; 526; 527; 528; 529; 531; 532; 533; 534; 536; 537; 544; 545; 546; 547; 548; 549; 550; 551; 552; 553; 554; 555; 556; 557; 558; 559; 561; 562; 563; 564; 565; 567; 601; 604; 606; 609; 611; 614; 617; 618; 620; 624; 625; 650; 653; 659; 702; 703; 704; 705; 707; 708; 710; 711; 712; 716; 717; 718; 720; 721; 722; 723; 724; 725; 726; 728; 729; 730; 731; 733; 734; 736; 737; 738; 740; 747; 748; 750; 752; 753; 754; 755; 756; 757; 758; 760; 761; 762; 763; 764; 765; 766; 767; 768; 770; 771; 772; 774; 775; 777; 778; 779; 780; 781; 782; 785; 786; 787; 788; 789; 790; 791; 794; 795; 797; 798; 799; 800; 801; 802; 804; 806; 807; 901; 904; 905; 907; 908; 909; 910; 912; 913; 914; 916; 917; 918; 920; 921;
approvals, Mexico -- 530;
approvals, U.S., as drugs -- 105; 110; 118; 155; 156; 165; 166; 167; 168; 172; 181; 182; 186; 192; 193; 194; 195; 196; 197; 198; 199; 228; 231; 234; 250; 251; 252; 253; 254; 255; 256; 257; 258; 259; 262; 272; 605; 612; 615; 617; 618; 619; 626; 629; 631; 632; 633; 713; 933; 934; 935; 936; 941; 942; 943; 946; 949;
approvals, U.S., as medical devices -- 108; 109; 237; 241; 651; 652; 654; 656; 657; 658; 700; 701; 739; 808; 900; 922; 923; 924; 926; 927; 928; 929; 930; 931;
approved and marketed, currently, EU or European countries -- 102; 105; 108; 109; 110; 114; 115; 117; 118; 119; 120; 121; 123; 126; 128; 133; 136; 138; 141; 142; 143; 145; 147; 148; 149; 150; 151; 152; 155; 156; 157; 158; 159; 160; 162; 163; 165; 166; 167; 168; 169; 170; 172; 174; 175; 177; 178; 179; 181; 182; 184; 186; 187; 188; 189; 192; 193; 194; 195; 196; 197; 198; 199; 203; 204; 205; 206; 208; 209; 210; 211; 212; 213; 214; 216; 218; 220; 221; 222; 226; 227; 228; 234; 235; 239; 240; 243; 245; 248; 250; 252; 253; 254; 255; 257; 259; 262; 263; 264; 265; 267; 268; 269; 270; 272; 275; 276; 303; 308; 312; 408; 409; 410; 411; 412; 415; 433; 437; 438; 439; 441; 442; 455; 458; 460; 462; 463; 464; 465; 466; 467; 472; 473; 474; 476; 481; 482; 483; 489; 490; 491; 492; 493; 494; 495; 496; 501; 502; 503; 504; 513; 515; 517; 527; 529; 530; 531; 533; 550; 555; 561; 562; 564; 567; 601; 602; 604; 605; 609; 610; 611; 612; 615; 621; 622; 624; 625; 626; 650; 651; 652; 653; 654; 658; 659; 700; 701; 702; 703; 704; 705; 707; 708; 710; 711; 712; 713; 714; 716; 719; 721; 722; 723; 724; 725; 728; 729; 730; 731; 732; 733; 734; 736; 737; 739; 740; 742; 748; 749; 750; 752; 756; 758; 760; 761; 762; 764; 766; 767; 768; 770; 771; 772; 774; 775; 777; 778; 779; 785; 795; 796; 797; 798; 799; 800; 802; 803; 804; 806; 808; 900; 907; 908; 909; 910; 913; 917; 918; 920; 923; 924; 926; 927; 928; 929; 930; 931; 933; 934; 937; 941; 942; 943; 946; 949;
approved and marketed in the U.S. (currently) -- 105; 108; 109; 110; 114; 115; 117; 118; 119; 120; 123; 126; 128; 129; 133; 143; 145; 147; 148; 149; 150; 151; 152; 155; 156; 158; 159; 163; 165; 166; 167; 168; 169; 172; 174; 179; 181; 182; 184; 186; 187; 188; 189; 191; 192; 193; 194; 195; 196; 197; 198; 199; 201; 203; 204; 205; 206; 208; 209; 210; 211; 212; 213; 214; 216; 218; 220; 221; 222; 226; 227; 228; 231; 234; 237; 239; 240; 241; 243; 245; 250; 252; 253; 254; 255; 257; 259; 262; 264; 265; 267; 268; 269; 270; 272; 275; 276; 303; 306; 312; 408; 409; 410; 411; 424; 430; 431; 433; 436; 437; 441; 443; 455; 457; 458; 459; 460; 464; 466; 471; 472; 476; 477; 489; 491; 492; 493; 494; 496; 502; 503; 504; 513; 515; 517; 527; 529; 531; 533; 544; 549; 555; 561; 562; 564; 565; 567; 601; 604; 605; 609; 611; 612; 615; 617; 618; 619; 621; 622; 624; 626; 629; 650; 651; 652; 653; 654; 657; 658; 659; 700; 701; 702; 703; 704; 705; 707; 710; 711; 712; 713; 716; 721; 722; 723; 724; 725; 726; 728; 729; 730; 731; 734; 736; 737; 739; 748; 752; 755; 756; 758; 760; 761; 762; 763; 764; 766; 767; 768; 770; 771; 772; 774; 775; 777; 778; 779; 785; 797; 798; 799; 800; 802; 804; 806; 808; 900; 907; 908; 909; 910; 913; 914; 917; 918; 920; 923; 924; 926; 927; 928; 929; 930; 931; 933; 934; 935; 936; 937; 941; 942; 943; 946; 949;
approved and marketed in the U.S. (FDAapproved) -- 101; 105; 108; 109; 110; 114; 115; 117; 118; 119; 126; 128; 129; 133; 136; 143; 144; 145; 147; 149; 151; 152; 155; 156; 158; 159; 163; 165; 166; 167; 169; 172; 174; 175; 179; 181; 182; 186; 187; 189; 190; 192; 193; 194; 195; 196; 197; 198; 199; 201; 202; 203; 204; 205; 206; 208; 209; 210; 211; 212; 213; 214; 216; 218; 220; 221; 222; 226; 228; 230; 231; 234; 237; 239; 240; 243; 245; 250; 251; 252; 253; 254; 255; 256; 257; 259; 262; 264; 265; 267; 268; 269; 270; 272; 275; 303; 306; 312; 404; 408; 409; 410; 411; 424; 430; 431; 433; 436; 437; 441; 443; 455; 457; 458; 459; 460; 463; 464; 466; 471; 472; 476; 489; 491; 492; 493; 494; 496; 503; 504; 513; 515; 517; 527; 529; 531; 533; 549; 550; 555; 556; 561; 562; 564; 565; 567; 601; 604; 605; 609; 611; 612; 615; 617; 618; 619; 624; 626; 627; 629; 650; 651; 653; 654; 656; 658; 659; 700; 701; 702; 703; 704; 705; 707; 710; 711; 712; 713; 716; 721; 722; 723; 724; 725; 726; 728; 729; 730; 731; 733; 737; 740; 747; 748; 752; 756; 758; 760; 761; 762; 763; 764; 765; 766; 767; 768; 770; 771; 772; 774; 775; 777; 778; 779; 780; 795; 797; 798; 799; 800; 802; 806; 807; 808; 900; 907; 908; 909; 910; 913; 917; 918; 920; 923; 924; 926; 927; 928; 929; 930; 931; 932; 933; 934; 935; 936; 941; 942; 943; 946; 949;
approved, EU or European countries, but not actively marketed -- 101; 116; 146; 176; 238; 304; 498; 500; 507; 508; 546; 565; 566; 807; 915; 922; 938; 939;
approved, formerly, in EU or European countries -- 302; 309; 310; 313; 314; 414; 428; 432; 434; 440; 447; 448; 449; 454; 469; 509; 514; 519; 521; 522; 524; 526; 534; 537; 545; 548; 552; 554; 557; 563; 606; 616; 620; 631; 632; 657; 718; 720; 754; 765; 780; 781; 786; 794; 901; 904; 905; 916; 921; 932;
approved, formerly in U.S. (approval withdrawn) -- 190; 229; 230; 258; 307; 310; 311; 313; 314; 402; 403; 405; 406; 414; 419; 421; 425; 426; 427; 432; 434; 435; 444; 447; 448; 449; 450; 451; 454; 456; 469; 478; 479; 480; 508; 509; 510; 514; 519; 521; 522; 523; 524; 526; 528; 532; 534; 537; 545; 548; 550; 551; 552; 553; 554; 557; 559; 563; 606; 616; 620; 625; 631; 632; 633; 708; 717; 718; 720; 738; 753; 754; 780; 781; 786; 787; 788; 791; 794; 901; 904; 905; 916; 921; 932;
approved in U.S, but not marketed in U.S. (currently) (FDAapproved)(notMarketedUS) -- 101; 116; 146; 175; 202; 238; 251; 304; 305; 404; 412; 423; 463; 488; 498; 499; 500; 507; 511; 518; 520; 536; 546; 547; 556; 558; 614; 656; 733; 740; 747; 750; 757; 765; 782; 789; 790; 795; 801; 807; 912; 922; 939;
approved, U.S. -- 809;
biodefense stockpile, European countries -- 404; 484; 485; 538; 541;
biodefense stockpile (U.S.) -- 103; 104; 413; 484; 485; 486; 487; 488; 535; 536; 537; 539; 540; 541; 744; 745; 746; 789; 790; 911;
biogenerics, biosimilars, biocomparables, follow-on proteins, etc. (approval based on abbbreviated/comparative filing) -- 110; 132; 133; 134; 135; 137; 139; 140; 165; 166; 171; 178; 186; 207; 210; 219; 247; 248; 253; 255; 468; 477; 556; 617; 618; 619; 623; 626; 627; 630; 793; 796; 914;
bovine source warning, BSE country -- 422; 431; 433; 434; 443; 455; 463; 466; 514; 547;
bovine source warning, unknown/undocumented country -- 404; 517; 528;
CBER to CDER transfers -- 114; 115; 116; 117; 119; 126; 133; 136; 143; 158; 159; 163; 169; 179; 187; 189; 204; 206; 208; 209; 210; 211; 212; 213; 214; 216; 218; 220; 221; 222; 227; 239; 240; 243; 245; 264; 265; 267; 268; 269; 270; 272; 303; 306; 307; 311; 312; 601; 604; 609; 611; 612; 624; 795;
Collaborative R&D Agreements (CRADA) -- 233; 417; 486; 945;
Continuous Marketing Application (CMA) Pilot 2 Program -- 217;
controlled/gov�t distribution in European counties -- 404; 484; 485; 487; 536; 538; 541; 912;
controlled/gov�t distribution in U.S. -- 103; 104; 404; 427; 484; 485; 486; 487; 488; 499; 511; 536; 537; 539; 540; 541; 558; 744; 745; 746; 747; 789; 790; 911; 912; 916;
Drug Efficacy Study Implementation (DESI) -- 616;
exempt from CBER lot release requirements -- 115; 116; 117; 118; 119; 143; 145; 146; 147; 148; 159; 175; 179; 187; 189; 205; 208; 209; 210; 211; 213; 214; 220; 227; 243; 264; 268; 270; 272; 305; 306; 307; 311; 312; 313; 314; 650; 782;
expanded access/compassionate use -- 233; 792;
FDA application denied -- 141; 162;
FDA application withdrawn -- 176; 229; 236; 307; 311; 314; 402; 403; 432; 444; 447; 509; 521; 548; 554; 557; 559; 563; 566; 606; 616; 620; 717; 734; 738; 905; 916; 945;
FDA approved currently (FDAapproved) -- 105; 108; 110; 114; 115; 116; 117; 118; 119; 119; 126; 128; 133; 143; 144; 145; 146; 147;