Sanofi-Aventis yekuFrance yamhan’ara kuU.S. Food and Drug Administration kuti imbomisa kubvumidza kwayakaita genetic version yeLovenox yekambani inoderedza ropa.
Mukunyunyuta, Sanofi akati generic "haina kuenzana" kune yakaderera-molecular-uremu heparin chigadzirwa Lovenox, uye danho reFDA rinogona kukonzera Sanofi "kukuvadza kusingagadzirike."
Mushonga weSanofi-Aventis wechipiri unotengesa zvakanyanya Lovenox ianti-coagulant drug inouya iri jekiseni uye inoshanda kudzivirira kugwamba kweropa uye thrombosis yetsinga nekutetepa ropa mukati memuviri.
Kopi yemutengo wakaderera yeLovenox yakagadziridzwa kuburikidza nekubatana pakati peSandoz, iyo generic division yeNovartis, Basel, Switzerland-based drugmaker, uye Momenta, kambani yebiotechnology muCambridge, Massachusetts.
Mutauriri weSandoz akati genetic enoxaparin sodium jekiseni yakatanga kutumira nekukurumidza zvichitevera kubvumidzwa kweFDA munaChikunguru 23.
Sanofi anotenda kuti kubvumidzwa kweFDA "hakuna kuitwa zvinoenderana nezvisungo zvesangano," maererano neshoko rakatumirwa nemutauriri wekambani Jean-Marc Podvin. Akawedzera kuti kubvumidzwa "kunomutsa akati wandei mibvunzo yakakosha maererano neFDA yekuongorora maitiro ezvigadzirwa zvemishonga zvakaomarara izvo zvakakosha kutevera."
Sanofi anotsinhira kuti mushonga wavo wemushonga unogadzirwa kubva kumamorekuru eshuga anowanikwa muheparin, chinhu chinobva muura hwenguruve, wakaomarara zvekuti haukwanise kutevedzera nemazvo nevagadziri vemhando dzegeneric.
Patent paLovenox yakavharwa gore rapfuura nekuti Sanofi akarasisa US Patent uye Trademark Hofisi, maererano nemutongo wakapihwa neDare Repamusorosoro reUS. Chikumbiro chekambani chekudzoserwa patent chakarambwa neDare.
Chikumbiro chekambani iyi chekuti imbomira kutengesa mushonga uyu svondo rino chakarambwa nedare reU.S. District Court yeDunhu reColumbia.
Nyaya iyi, Sanofi-Aventis US LLC v. Food and Drug Administration 10cv1255, ichanzwikwa nedare redzimhosva musi wa17 Nyamavhuvhu.
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