每(měi )经(jīng )AI快(kuài )讯(xùn ),宣(xuān )泰(tài )医(yī )药(yào )(688247)5月(yuè )12日(rì )晚(wǎn )间(jiān )公(gōng )告(gào ),近(jìn )日(rì ),公(gōng )司(sī )收(shōu )到(dào )美(měi )国(guó )食(shí )品(pǐn )药(yào )品(pǐn )监(jiān )督(dū )管(guǎn )理(lǐ )局(jú )(简(jiǎn )称(chēng )“美(měi )国(guó )FDA”)的(de )通(tōng )知(zhī ),公(gōng )司(sī )向(xiàng )美(měi )国(guó )FDA申(shēn )报(bào )的(de )达(dá )格(gé )列(liè )净(jìng )二(èr )甲(jiǎ )双(shuāng )胍(guā )缓(huǎn )释(shì )片(piàn )的(de )简(jiǎn )略(luè )新(xīn )药(yào )申(shēn )请(qǐng )获(huò )得(dé )暂(zàn )时(shí )批(pī )准(zhǔn )。本(běn )次(cì )达(dá )格(gé )列(liè )净(jìng )二(èr )甲(jiǎ )双(shuāng )胍(guā )缓(huǎn )释(shì )片(piàn )获(huò )得(dé )美(měi )国(guó )FDA的(de )暂(zàn )时(shí )批(pī )准(zhǔn ),标(biāo )志(zhì )着(zhe )该(gāi )产(chǎn )品(pǐn )满(mǎn )足(zú )了(le )仿(fǎng )制(zhì )药(yào )的(de )所(suǒ )有(yǒu )审(shěn )评(píng )要(yào )求(qiú )。但(dàn )该(gāi )产(chǎn )品(pǐn )在(zài )美(měi )国(guó )的(de )专(zhuān )利(lì )尚(shàng )处(chù )于(yú )保(bǎo )护(hù )期(qī )内(nèi ),公(gōng )司(sī )需(xū )在(zài )相(xiàng )关(guān )专(zhuān )利(lì )到(dào )期(qī )并(bìng )获(huò )得(dé )美(měi )国(guó )FDA最(zuì )终(zhōng )批(pī )准(zhǔn )后(hòu )方(fāng )可(kě )获(huò )得(dé )在(zài )美(měi )国(guó )市(shì )场(chǎng )销(xiāo )售(shòu )该(gāi )产(chǎn )品(pǐn )的(de )资(zī )格(gé )。
每(měi )日(rì )经(jīng )济(jì )新(xīn )闻(wén )