Please leverage the article enclosed to complete 2 different OM Actions(Week 4 OM in Action and Week 8 OM in Action)You can align it to quality with the attached the Week 4 OM in Action template and t

T he a g en cy s a id i t i s e v a lu atin g w heth er t h e l o w a m ou n ts o f t h e c h em ic a l, k n ow n a s N DM A, pose a r is k t o p atie n ts . I t s a id i t w ou ld m ake t h at a ss e ss m en t a v a ila b le p u bli c ly a s s o on a s p oss ib le .

Z an ta c i s s o ld b y S an ofi an d g en eric a lly u n der t h e n am e r a n it id in e. T he F D A s a id t h at w hile N DM A m ay c a u se h arm i n l a rg e a m ou n ts , t h e l e v els i t i s fi ndin g i n p re li m in ary t e sts “ b are ly e x ce ed a m ou n ts y o u m ig h t e x p ect t o fi nd i n c o m mon f o od s.” This copy is for your personal, non-commercial use only . To order presentation-ready copies for distribution to your colleagues, clients or customers visit https://www .djreprints.com.

https://www.wsj.com/articles/fda-finds-probable-carcinogen-in-some-versions-of-zantac-1 1568389534 U.S .

FD A F in ds P ro bab le C arc in ogen i n S om e Vers io n s o f Z an ta c Agen cy i s e va lu atin g w heth er l o w a m ou nts o f c h em ic a l p ose r is k t o p atie n ts Z an ta c i s s o ld b y S an oi a n d g en eric a lly u nder t h e n am e r a n it id in e. P HO TO : R O BER T P R ATTA R EU TE R S U pdate d S ep t. 1 3 , 2 0 19 5 1 9 p m E T B y T hom as M . B urto n 11/19/2019 FDA Finds Probable Carcinogen in Some V ersions of Zantac - WSJ https://www.wsj.com/articles/fda-finds-probable-carcinogen-in-some-versions-of-zantac-1 1568389534 2/3 The c h em ic a l i s p art o f a c la ss o f c o m pou n ds c a lle d n it r o sa m in es t h at a re f o u n d i n w ate r a n d i n f o od s l i k e m ea ts , d air y p ro d u cts a n d v eg eta b le s. T he F D A acte d a ft e r a n o n li n e phar m acy ca lle d V ali s u re L L C , o f N ew H av en , C on n., t u rn ed u p t h e c o n ta m in atio n i n t e stin g t h e q u ali t y o f b atc h es o f m ed ic a tio n s t h at i t s e lls .

R an it id in e, o rig in ally t h ou gh t o f a s a n u lc e r d ru g, n ow i s a p pro ved b oth f o r t r e a tm en t a n d pre v en tio n o f u lc e rs i n t h e s to m ach a n d i n te stin es a s w ell a s f o r g astr o eso p hag ea l r e fl ux dis e a se , o r h ea rtb u rn .

M an y g en eric d ru gs f o r h ig h b lo od p re ss u re a lr e a d y h av e b een f o u n d t o b e c o n ta m in ate d b y l o w le v els o f N DM A a n d r e la te d c a rc in ogen ic c h em ic a ls . T he F D A h as g ra p ple d w it h t h e f o r m ore th an a y ea r, p rin cip ally i n g en eric d ru gs, i n clu din g t h e b lo od -p re ss u re d ru g v a ls a rta n m an ufa ctu re d i n C hin a a n d I n dia .

T he F D A s a id i t c o u ld n’t i m med ia te ly s a y w heth er a n y o f t h e g en eric Z an ta c p ro d u cts w ere m ad e i n C hin a o r I n dia .

“S an ofi t a kes p atie n t s a fe ty s e rio u sly , a n d w e a re c o m mit te d t o w ork in g w it h t h e F D A ,” S an ofi sa id . “ Z an ta c O TC [ o ver t h e c o u n te r] h as b een a ro u n d f o r o ver a d eca d e a n d m eets a ll t h e sp ecifi ed s a fe ty r e q u ir e m en ts f o r u se i n t h e O TC m ark et.” T he F D A h as p re v io u sly a ck n ow le d ged t h at t w o m illi o n o r m ore p eo p le w orld -w id e h ad b een ex p ose d t o t h e c h em ic a l i n b lo od p re ss u re d ru gs. T hese i n clu ded g en eric d ru gs l i k e v a ls a rta n , ir b esa rta n a n d l o sa rta n . MORE U.S. NEWS New Government T ool Flags Nursing-Home Abuse Nove m ber 1 9 , 2 0 19 Doctor Says T rump Exam Was Routine Nove m ber 1 8 , 2 0 19 Powell Meets With T rump, a Frequent Critic, to Discuss Economy Nove m ber 1 8 , 2 0 19 U.S. Fails to Counter Chinese Ef forts to Recruit Scientists, Acquire Research, Senate Report Says Nove m ber 18 , 2 0 19 • • • • 11/19/2019 FDA Finds Probable Carcinogen in Some V ersions of Zantac - WSJ https://www.wsj.com/articles/fda-finds-probable-carcinogen-in-some-versions-of-zantac-1 1568389534 3/3 Over t h e p ast y ea r, a s e rie s o f r e ca lls h av e b een i s s u ed f o r h yp erte n sio n d ru gs m ad e b y v a rio u s co m pan ie s, l a rg ely f r o m r a w m ate ria l f a cili t ie s i n C hin a a n d I n dia . T he c o n ta m in atio n , w hile s m all, h as r a is e d q u estio n s a b ou t t h e s a fe ty o f g en eric d ru gs, m an y o f w hic h c o m e f r o m r a w m ate ria ls i n t h ose c o u n tr ie s.

N ot a ll g en eric b lo od -p re ss u re p ro d u cts a re a ff ecte d .

T he F D A h as s a id t h at t h e i m pu rit ie s i n q u estio n r e su lt e d i n ad verte n tly f r o m a m an ufa ctu rin g pro ce ss. R eg ard in g t h e i s s u e w it h v a ls a rta n , t h ere m ay b e o n e a d dit io n al c a se o f c a n ce r a m on g 8,0 00 p eo p le i f t h ey t o ok t h e h ig h est d ose o f t h e d ru g c o n sta n tly f o r f o u r y ea rs , t h e a g en cy s a id .

In a fi li n g t h is w eek w it h t h e F D A k n ow n a s a c it iz e n ’s p etit io n , V ali s u re s a id i t s a n aly sis “ re v ea ls t h e a b ili t y o f t h e r a n it id in e m ole cu le t o f o rm N DM A” i n c o n dit io n s l i k e t h ose i n t h e hu m an b od y, p erh ap s s u ggestin g a p hen om en on d iff ere n t f r o m t h at i n vo lv in g t h e b lo od - p re ss u re m ed ic in es.

W rit e to T hom as M . Bu rto n a t to m .b u rto n @ wsj.c o m Copyright © 2019 Dow Jones & Company , Inc. All Rights Reserved This copy is for your personal, non-commercial use only . To order presentation-ready copies for distribution to your colleagues, clients or customers visit https://www .djreprints.com.