She has worked on numerous media teams for advisory committee meetings and drug approvals for INVOKANA, ZYTIGA, LATUDA, PROCRIT, LAP-BAND, Aranesp, Avelox, BOTOX, Cipro, Diovan, Elidel, Kineret, Abatacept, Rimonabant, Novolog, Treanda, Viracept
and Zoloft, among others.
The assessment affects nineteen centrally authorised medicines as well as various medicines that have been nationally authorised: Avastin, Bondenza, Bondronat, Bonviva, Cellcept, Fuzeon, Herceptin, Invirase, Mabthera, Mircera, Neorecormon, Pegasys, Roactemra, Tamiflu, Tarceva, Viracept
, Xeloda, Xenical and Zelboraf.
The HIV drug was approved by the US Food and Drug Administration in 1997, and is sold under the brand name Viracept
Since the Viracept
case, however, genotoxic impurities are now more in the focus of the authorities.
5 (intermediate 0 (low penetration) penetration) Nucleoside or nucleotide reverse transcriptase inhibitors Retrovir (zidovudine) Emtriva Videx (didanosine) (emtricitabine) Ziagen (abacavir) Epivir (lamivudine) Viread (tenofovir) Zerit (stavudine) Nonnucleoside reverse transcriptase inhibitors Viramune (nevirapine) Sustiva (efavirenz) Intelence (etravirine) * Protease inhibitors Crixivan (indinavir) Reyataz (atazanavir) Aptivus (tipranavir) + (+ RTV) RTV Kaletra (lopinavir + Reyataz + RTV Invirase (saquinavir) RTV) + RTV Agenerase[dagger] Prezista (darunavir) + Norvir (ritonavir) (amprenavir) + RTV RTV Viracept
(nelfinavir) Entry inhibitors Selzentry Fuzeon (enfuvirtide) (maraviroc) * Integrase inhibitors Isentress (raltegravir) * RTV = ritonavir (Norvir).
BASEL, Switzerland, July 24 /PRNewswire/ -- The European Committee for Human Medicinal Products (CHMP) has confirmed that the presence of an impurity called ethyl methanesulfonate (EMS) in Roche's Viracept
(nelfinavir mesylate) did not increase patients' risk of developing cancer.
Roche, in agreement and co-operation with health authorities (EMEA and Swissmedic), is recalling all batches of Viracept
powder and tablets in Europe and some other regions of the world.
Tests on batches of the drug Viracept
, whose generic name is nelfinavir, revealed higher than normal quantities of methane sulfonic acid ethyl ester.
The drug, Viracept
, which is used by more than 500 UK patients, was recalled because batches were found to contain too high a level of a chemical that can cause cancer.
The company already sells its Viracept
and Invirase drugs at no profit to Sub-Saharan African and in other countries that the United Nations defines as least developed.
Pls--Agenerase, Crixivan, Kaletra, Viracept
, Norvir, Fortovase, Invirase
A typical anti-HIV cocktail consists of one protease inhibitor, such as Kaletra or Viracept
, and two nucleoside reverse transcriptase inhibitors, such as Zerit, Retrovir, and Videx.