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1 1% 1 mg 1 mg 2 CTD 6

2 Section Introduction H 1 descarboethoxyloratadinesch SCH O OC 2 H 5 Cl N N JAN Loratadine (JANINN) ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6] cyclohepta[1,2-b]pyridin-11-ylidene)-1- piperidinecarboxylate : mg mg 2 1% 1 mg 1 mg % 1 mg 1 mg 1 1 mg 1g mg.5g 1 1 mg 1g mg mg 1 1 1

3 1% 1 mg 1 mg 2 CTD 6

4 Section Toxicology Written Summary i

5 Section Toxicology Written Summary AUC AUC -24hr BUN C 3hr Cmax GLP GOT GPT SCH TK area under concentration-time curve 24 AUC blood urea nitrogen 3 maximal plasma drug concentration Good Laboratory Practice glutamic oxaloacetic transaminase glutamic pyruvic transaminase descarboethoxyloratadine toxicokinetics 1

6 Section Toxicology Written Summary GLP TK 1 TK a 3TK a mg/kg2 mg/kg 5 mg/kg 5 mg/kg 2 mg/kg mg/kg 125 mg/kg mg/kg158 mg/kg 2 mg/kg 5 mg/kg mg/kg 2 mg/kg 158 mg/kg mg/kg mg/kg 2 mg/kg 2 mg/kg mg/kg/ 25 mg/kg/ 25 mg/kg/ 2

7 Section Toxicology Written Summary 5 mg/kg/ 75 mg/kg/ 25 mg/kg/ SCH Cmax AUC Cmax AUC SCH Cmax AUC 25 5 mg/kg/ 5 75 mg/kg/ SCH AUC AUC mg/kg/ 5 mg/kg/ 2.5 mg/kg/ mg/kg SCH Cmax AUC GLP mg/kg/ GPT GOT mg/kg/ GPT GOT A A mg/kg/ GPT GOT 3 GPT GOT 24 mg/kg/ 3

8 Section Toxicology Written Summary P-56 7 SD mg/kg A7 2 mg/kg 125 mg/kg 2 mg/kg 32 mg/kg 8 mg/kg 5 mg/kg mg/kg mg/kg 125 mg/kg 5 mg/kg 2 mg/kg 5 mg/kg 2 4

9 Section Toxicology Written Summary mg/kg 125 mg/kg P-56 3 SD mg/kg A mg/kg mg/kg mg/kg 2 mg/kg 158 mg/kg mg/kg 158 mg/kg 1 2 mg/kg 158 mg/kg 251 mg/kg 251 mg/kg 316 mg/ kg 5 mg/kg P mg/kg A8 2 mg/kg 2 mg/kg SD mg/kg/ B9 5

10 Section Toxicology Written Summary 75 mg/kg/ 1 mg/kg/ 1 mg/kg/ 1 15 mg/kg/ SD mg/kg/ 3 TK mg/kg/ 15 mg/kg/ 75 mg/kg/ 75 mg/kg/ 5 25 mg/kg/ C SCH Cmax AUC - 24hr Cmax AUC SCH Cmax AUC 25 5 mg/kg/ 5 75 mg/kg/ SCH AUC AUC mg/kg/ 25 mg/kg/ 5 mg/kg/ 75 mg/kg/ 5 mg/kg/ 75 mg/kg/ BUN mg/kg/ 1 75 mg/kg/ 1 25 mg/kg/ /3 25 mg/kg/ D SD mg/kg/ 1 TK 25 mg/kg GLP 6

11 Section Toxicology Written Summary.4 mg/kg/ * D SCH Cmax AUC 5 mg/kg/ mg/kg/ 1 25 mg/kg/ mg/kg/ GPT GOT GPT GOT A mg/kg/ 1.4 mg/kg/ E13 GPT GOT mg/kg/ mg/kg/ 2 4 mg/kg/ 3 GPT mg/kg/ 1 4 mg/ kg/ 3 GOT 5 4 mg/ kg/ 1 A GPTGOT A * mg/ mg/ kg7 24. kg mg/kg/ mg/kg/.4 mg/kg/ 7

12 Section Toxicology Written Summary D A GPT GOT A GPTGOT GPT GOT A mg/kg/ F14 GPT GOT A A GPT GOT mg/kg/ 3.4 mg/kg/ G15 SCH C 3hr GPT GOT mg/kg/ 1 12 mg/kg/ mg/kg/ mg/kg/ 1 GPT GOT GPT GOT A A GPTGOT 8

13 Section Toxicology Written Summary GPT GOT 24 mg/kg/

14 Section Toxicology Written Summary mg/kg mg/kg 125 mg/kg 2 mg/kg 5 mg/kg , mg/kg 251 mg/kg 2 mg/kg 158 mg/kg mg/kg 158 mg/kg 2 mg/kg 5 mg/kg ).4 mg/kg/ * mg/kg2 mg/kg 5 2 mg/kg * mg/ mg/ kg7 24. kg mg/kg/ mg/kg/.4 mg/kg/ 1

15 Section Toxicology Written Summary M F mg/kg mg/kg 125 < 125 P-56 3 M F a 158 < 158 P-56 6 M F > 2 > MF > 2 1 P MF > mg a 2 mg/kg mg/kg/ 25 mg/kg/ mg/kg/ SCH AUC AUC SCH Cmax AUC 25 mg/kg/ 32 mg/kg/ mg/kg/ 128 mg/kg/ mg/kg/ 5 mg/ kg/ 2.5 mg/kg/ 7) Cationic Amphiphilic Drug: CAD 8-1) - 1,11) CAD mg/kg/ 1 mg/kg/

16 Section Toxicology Written Summary mg/kg/ GPT GOT mg/kg/ GPT GOT A A mg/kg/ GPTGOT 3 GPT GOT 24 mg/kg/ 3 24 mg/kg/ mg/kg/ mg/kg/ / mg/kg/ , 5, < , 5, ,.5, 1, 8, 32, a , 12, , 24, mg a

17 Section Toxicology Written Summary mg/kg/ 6 a 14 MF M 28 M 7 M MF 11 MF Cmaxng/mL AUC -24hr ng hr/ml SCH SCH C 3hr ng/ml SD b SCH n=4 / 6 / 1 mg a 2 b C 3hr mg/kg/ 3/ mg/ kg/ 6/6 3/ p SN 99Three-month oral toxicity study of SCH in rats 19 3 SN 1Three-month oral toxicity study of SCH in cynomolgus monkeys 19 4 Gibson JP, Huffmann KW, Newberne JW. Preclinical safety studies with terfenadine. Arzneim.- Forsch./Drug Res. 1982;22: SN 75Rising dose tolerance study of SCH in cynomolgus monkeys 19 7 Kodavanti UP and Mehendale HM. Cationic amphiphilic drugs and phospholipid storage disorder. Pharmacol Rev 199;42(4): Hostetler KY. Molecular studies of the induction of cellular phospholipidosis by cationic amphiphilic drugs. Fed Proc 1984; 43(11): Hostetler KY, Reasor MJ, Walker ER, Yazaki PJ and Frazee BW. Role of phospholipase A inhibition in amiodarone pulmonary toxicity in rats. Biochim Biophys Acta 1986;875(2):4-5. 1Lulmann H, Lullmann-Rauch R and Wassermann O. Lipidosis induced by amphiphilic cationic drugs. Biochem Pharmacol 1978;27(8):

18 Section Toxicology Written Summary ;8(4): Three-month low-dose toxicity study of loratadine in rats 19 13SN 314Loratadine (SCH 29851): 28-day diet versus gavage absorption study in male rats (Plasma concentrations of SCH and SCH 34117) 19 14

19 1% 1 mg 1 mg 2 CTD 6

20 Section Toxicology Tabulated Summary A B C D E F G i

21 mg/kg/ a SD 7, 125, 2, 32, 5, 8, 126, 2 SC SD 3, 158, 2, 251, 316, 4, 5 SC 7 15, SC SD 6 1, 2.5, 5, 25, 5, 75, 1, 15 SPRI 35 SD 6 3, 25, 5, 75 SPRI 36 SD 28 1, 2.5, 5, 25 SC ,.5, 1.5, 4 SC 41 GLP P ,.5, 1.5, 4 A D , 4, 12, 24 SC 27 SCSchering CorporationSPRI Schering-Plough Research Institute A a Section Section Toxicology Tabulated Summary

22 GLP mg/kg/ Section 3 SD 6 25, 5, TK SD D , 12, Section Toxicology Tabulated Summary 2

23 (1 of 3) Cmax (ng/ml) AUC -24hr (ng hr/ml) mg/kg/ SCH SCH M+F SD 31 TK 1 M a D TK 1 M a 7 1 TK 28 M b mg a (ng Eq hr/ml) b SN 314Loratadine (SCH 29851): 28-day diet versus gavage absorption study in male rats (Plasma concentrations of SCH and SCH 34117) 19 Section Toxicology Tabulated Summary 3 (ng/ml) mg/kg/ a SCH M+F 4 C 3hr C 3hr C 3hr M+F 8 C 3hr C 3hr b 72 C 3hr n=4 / / 1 mg a C 3hr mg/kg/ 3/ mg/kg/ 6/6 3/6 b SN 1Three-month oral toxicity study of SCH in cynomolgus monkeys 19

24 (2 of 3) Section Toxicology Tabulated Summary 4 2 Cmax AUC -24hr

25 (3 of 3) Section Toxicology Tabulated Summary C 3hr SD

26 a (%) GX-11-I (19, ) 1.6 P-56 P-56 B-5127 (2, ) (19, ) 98 P (19, ) D a % Section Toxicology Tabulated Summary 6

27 A (1 of 2) SD 7 SD 3 P-56 P-56.4%.4% M1, F1 M1, F1 (mg/kg) M125 2, F125 M251, F158 (mg/kg) a a M, F,, 1 1, 6 7, 1 7, 9 1, 1 1, 1 1, 1,, 1, 3, 1 3, 1 5, 2 2, 6 MF MF MF MF M F MF M MF MF MF M MF MF F MF MF MF MF F M MF MF F MF MF MF F MF MF MF MF MF MF MF b MF b b b MF MF MF MF MF MF M F F F MF MF MF MF MF MF MF MF MF MF MF M M MF M M F MF F MF MF MF MF MF 2 a.4% b 32 mg/kg 8 mg/kg Section Toxicology Tabulated Summary

28 A (2 of 2) 7 15 P-56 (mg/kg) MF>2 M1, F1 M1, F1 (mg/kg) a M, F,,,,, X X 2 X a Section Toxicology Tabulated Summary 8

29 B SD % 1 M8, F8 mg/kg/ a a 5 75 a 1 15 M, F,,,,,,,,, 2, M MF MF b a.4% b Section Toxicology Tabulated Summary 9

30 C 3 (1 of 2) SD 6 2 TK < 25 mg/kg/ 3.4% 36 CTD GLP mg/kg/ 1 a 2 a TK 14 b M: F: M: F: M: 24 F: 24 M: 24 F: 24 M: 24 F: 24 Cmaxng/mL AUC -24hr (ng hr/ml) SCH Cmaxng/mL AUC -24hr (ng hr/ml) M: 2 F: 2 M: 2 F: 2 M: 2 F: 2 M: 2 F: 2 M: 2 F: 2 1 c 2 c 1 c (% d ) g 73.3 g 73.4 g 69.9 g (% d ) g 61.3 g 6.6 g 58. g e BUN (mg/dl) (% f ).35 g.33 g %.43% g.312 g %.42% g % a.4% b n=4 1, 3, 6, 8, 12, 24 c d 2 % e 1 f % Section Toxicology Tabulated Summary

31 C 3 (2 of 2) 36 mg/kg/ 1 a 2 a M: 2 F: 2 M: 2 F: 2 M: 2 F: 2 M: 2 F: 2 M: 2 F: 2 (19) (2) (2) (2) (2) (2) (2) (2) (2) (2) (19) (2) (2) (2) (2) (2) (2) (2) (2) (2) (19) (2) (2) (2) (2) (2) (2) (2) (2) (2) (19) (2) (2) (2) (2) (19) (2) (2) (2) (2) (19) (2) (2) (2) (2) (19) (2) (2) (2) (2) a.4% Section Toxicology Tabulated Summary

32 D 1 SD TK 2.5 mg/kg/ 1 26TKD-1932 CTD TK GLP TK mg/kg/ a TKD-1932 AUC -24hr (ng hr/ml) 31 b M: F: M: F: M: F: M: 28 F: 1214 SCH c d M: F: M: F: M: F: M: 9 F: 1688 SCH c 3796 M: 1 F: 1 M: 1 F: 1 M: 1 F: 1 M: 1 F: 1 1 e 1 e 1 e (% f ) g g g a b n=4.25,.5, 1, 2, 4, 6, 24 c (ng Eq hr/ml) d n=4 8.25,.5, 1, 2, 4, 6, 24 e f % g 1 Section Toxicology Tabulated Summary

33 E mg/kg/ a M: 3 F: 3 M: 3 F: 3 M: 3 F: 3 M: 3 F: 3 (kg) GPT GOT A IgM-IgG A IgM 1 1 (3) (3) (3) (3) (3) (3) (3) (3) a 41 CTD GLP Section Toxicology Tabulated Summary

34 F D-276 CTD GLP mg/kg/ a M: 3 F: 3 M: 3 F: 3 M: 3 F: 3 M: 3 F: 3 (kg) GPT GOT A IgM-IgG A IgM b a b Section Toxicology Tabulated Summary

35 G mg/kg/ 3 mg/kg/ a M: 2 F: 2 M: 2 F: 2 M: 2 F: 2 M: 2 F: 2 TKC b 3h (ng/ml) ND, ND ND, 11 ND, 26 ND, ND ND, ND ND, 137 SCH , 44 93, , , 87 47, , 382 b (kg).9, 1.3.9, 1. 1.,.9 1., , 1..7, , 1.3.9, , , , , , , , , 1.1 c GPT U/L (5, 44) (45, 23) (41, 42) (25, 115) (784, 25) (17, 112) (322, 48) (4, 38) 13 (81, 47) (48, 26) (6, 52) (33, 46) (65, 24) (41, 31) (32, 47) 1 (371, 46) GOT U/L (33, 45) (42, 41) (78, 42) (34, 41) (219, 36) (92, 91) (13, 42) (37, 43) 13 (41, 28) (48, 39) (62, 39) (4, 4) (47, 29) (28, 47) (44, 34) 1 (177, 41) --ND a b c 27 CTD GLP Section Toxicology Tabulated Summary

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