《戒毒癮學名藥之一》獨家!FDA 通過第一個戒毒癮舌下片Buprenorphine/ Naloxone 學名藥 印度Dr. Reddy's拔得頭籌!股價開盤大漲3%

美國FDA昨天(14日)宣布,核准第一個戒毒癮舌下片Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue)學名藥,Dr. Reddy's搶得頭籌(美國學名藥大廠 Mylan也同時拿到),後續會不會宣布Launch at Risk 值得追蹤,會對台灣美時產生甚麼的影響,後續Genet報導。看起來,這次FDA為了減少毒癮的氾濫,對戒毒癮的學名藥是加速審核了! 

Dr. Reddy's和原廠的專利官司有機會在第三季見真章,如果贏了,當然就是搶入市場 (但是也不要忘了,後續還有三個專利的官司等著學名藥廠,未來的輸贏還不知道),如果輸了,當然就不會上市,只是如果輸了,對後續美時的專利官司的影響也會很大。 現在就看,Dr. Reddy's在官司宣判之前,會不會採取Launch at Risk?? 

The U.S. Food and Drug Administration today approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence.

"The FDA is taking new steps to advance the development of improved treatments for opioid use disorder, and to make sure these medicines are accessible to the patients who need them. That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access," said FDA Commissioner Scott Gottlieb, M.D. "The FDA is also taking new steps to address the unfortunate stigma that's sometimes associated with the use of opioid replacement therapy as a means to successfully treat addiction. Patients addicted to opioids who are eventually treated for that addiction, and successfully transition onto medicines like buprenorphine, aren't swapping one addiction for another, as is sometimes unfortunately said. They're able to regain control of their lives and end all of the destructive outcomes that come with being addicted to opioids. When coupled with other social, medical and psychological services, medication-assisted treatments are often the most effective approach for opioid dependence. (資料來源: 美國FDA)

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