Ty­onex ARVs gets US FDA cer­ti­fi­ca­tion

Daily Trust - - HEALTH - By Nahimah Ajikanle Nu­rudeen, La­gos

The United States Food and Drug Ad­min­is­tra­tion (FDA) has val­i­dated the Ty­onex brand of Anti-Retro­vi­ral (ARVs) drugs as safe and de­void of any sub­stance ca­pa­ble of caus­ing in­jury or death to HIV pa­tients.

The FDA Case/Sam­ple Re­port, is­sued from its Foren­sic Chem­istry Cen­tre, in Cincin­nati, Ohio and dated March 3, 2014, was signed by Adam Lan­zarotta, PhD and con­curred by four oth­ers.



Health Or­gan­i­sa­tion (WHO) has also been sent a copy of the re­sult of the anal­y­sis, which was at the in­stance of the HIV/AIDS ad­vo­cacy group, Treat­ment Ac­tion Move­ment (TAM).

It also vin­di­cates Ty­onex Nigeria Ltd, the man­u­fac­turer and mar­keter of the ARVs, which has al­ways main­tained that its prod­ucts were safe.

Re­act­ing to the cer­ti­fi­ca­tions, Ty­onex Man­ag­ing Di­rec­tor Pharm. Em­manuel Ty­ohemba Agba said the val­i­da­tion is a wel­comed de­vel­op­ment to the com­pany’s cred­i­bil­ity of the FDA re­sult as in­ter­na­tion­ally ac­claimed agency for cer­ti­fi­ca­tion of phar­ma­ceu­ti­cal prod­ucts.

He said, “To God be the glory; it is the Lord’s do­ing and it is mar­velous in our eyes. I am de­lighted that no less a body than the FDA has waded into this mat­ter, and the re­sults are there for ev­ery­one to see. This Re­port val­i­dates what NAFDAC did, it au­then­ti­cates what LASUTH Lab did, and it also con­firms what the In­de­pen­dent Pub­lic Anal­y­sis Lab­o­ra­tory in La­gos did.”

Ty­onex had come un­der fire from TAM and NEPWHAN, which ve­he­mently ob­jected to the pre­sen­ta­tion, pack­ag­ing and lit­er­a­ture of its brand of ARVs. They had ex­pressed their dis­plea­sure with the lit­er­a­ture, which they claimed lacked clar­ity. The groups had also picked holes with the phys­i­cal prop­er­ties of the tablets, claim­ing it broke eas­ily while its bit­ter taste made it un­de­sir­able by pa­tients.

At one point, NEPWHAN blamed the Ty­onex brand of ARV for the death of its mem­ber, al­though that claim has not been ver­i­fied by com­pe­tent med­i­cal au­thor­i­ties. Amidst the con­tro­versy, the Federal Govern­ment sus­pended the ARV and launched an in­ves­ti­ga­tion into the claims.

This also led to a se­ries of en­gage­ments in which Ty­onex made a firm com­mit­ment to work with TAM and other stake­hold­ers to con­tinue to ad­dress all con­cerns.

Ty­onex MD noted that this was the first ever FDA clear­ance for a Nige­rian-man­u­fac­tured ARV, Pharm Agba said the de­vel­op­ment bodes well for the Phar­ma­ceu­ti­cal Man­u­fac­tur­ing Group (PMG) of the Man­u­fac­tur­ers As­so­ci­a­tion of Nige­rian (MAN).

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