Tyonex ARVs gets US FDA certification
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).