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Dailypharm

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Ѵ޻ ̱ 㰡 2..., ù ñ
õ 2019-02-08 06:00:55
Ѵ޻ ̱ 㰡 2..., ù ñ
õ 2019-02-08 06:00:55
[DP]  ̿ùз FDA 㰡...ѹ-SK̿ մ

̱ Ǿǰ Ʈ


ʺ ̱ ҽ ִ. Z̿ǽ ü ̿ùз ǰ ִ Ը 㰡 ߴ. ݱ ̱ 忡 Ǿǰ ޸ ʸ .

߿ Z̿ǽ ̿ùз FDA 㰡

7 迡 ü Ÿ 1 ̱ ǰǾǰ(FDA) 㰡 ޾Ҵ. FDA Ÿ ָ̰ 㰡 ߴ. ̱ ǰ ֺ(Jeuveau).

  ֺ ǰ(ڷ: 罺)
Ÿ ̱ , ij  2100 ̻ Ը ӻ 3 ȿ ߴ. cGMP ֽż 忡 ޵ȴ.

2013 9 罺 Ÿ 5 5 ȭ ܰ迡 ߴ.

Ѵ޸ 2 ü Ǿǰ ̱ 忡 ߴ.

ռ 19 Z̿ǽ ƮƮ FDA ȹߴ. ƮƮ ν ׾ ƾ ̿ùз.

迡 ü Ǿǰ ̱ ó ʸ Ѵ.

߽ž 3 10 ̱ ...ټ ̹

ݱ FDA 㰡 Ǿǰ 10 ž 3 Ұϴ.

2003 LGȭ ׻ Ƽ갡 ž ̱ ߴ. 2014 ƿƼ úƮο ̾ 2016 5 SKɹĮ 캴ġ ۽ƿ FDA ޾Ҵ.

  ֿ Ǿǰ ̱ 㰡 Ȳ(ڷ: , NH)

ֱٿ ̿ùз Ȱ ̱ ִ. Ʈ 2016 ̵ ̿ùз ÷Ʈ Ʈø 긶 3 ̿ùз ̱ 㰡 ޾Ҵ. Z̿ǽ ÷ý ƮƮ 2 ̱ ι޾Ҵ. FDA 㰡 ̿ùз 17 5 ǰ̴.

ѹ̾ǰ Ҹ, ޷, Ʈ ׹ͽý ž ׸ ǰ ̱ 忡 ߴ.

ž ؼ ž, ׸ ̱ Ҹ ǰ ʴ ̴. ǰ ȯ ȭ 忡 ǰ £ з ǰ ߴ. Ҹ ƽƮī ƯҼ ̱ ߸ŵ ׸ ǰ ġ ߴ. ֱ ̱ ۽ƿ ʱ ܰ.

̱ ǰ ̿ùз ǰ ̱ 忡 Ȯϴ .

ֱ ȭ ǥ Ʈ ÷Ʈ 4б ̱ 7000޷( 780) ߴ. б 7100޷ ټ ϶ 1 25900޷( 2900) ÷ȴ. Ǿǰ ̱ ø ִ Ը ̴.

ڴ ̿ùз ݰ£ Ը ̶ Ѱ谡 Ǿǰ Ѵٴ ο âؾ ϴ žຸٴ ټ ϴ١ ߴ.

ش ÷Ʈ 4 ̿ùз(Ʈ 2, Z̿ǽ 2) ߻ ȴ.

ǰ "Ÿ ...彺 ɼ"

Ÿ 彺 ִ ǰ̶ ȣ ޴´.

ټ ܽ ֺ ʳⰣ 忡 '彺' ߴ. 彺 ڱ ߰, ȿ 鿡 񿭵 ÿ 25~30% ݰ ٴ . ޿ ̿ 켱 ϱ డѿ Ӵٴ 򰡹޴´. FDA 㰡 罺 ְ ִ 25% ġھҴ.

ȣ ֺ ̱ 2019 1920޷ ϰ, 2026 340޷ ߴ. ̿뼺 о Ȯϸ鼭 2026 ۷ι 37550޷ ߴ.

ѱ 7 Ÿ ̱ 2% 2025 16% ߴ.

Ÿ ó ̱ 㰡 900kD 彺 ǰ̴١鼭 彺 оߴ 9޷ ̱ Ϲ ǰ ŭ ۽Ʈ ̿ùз Ÿ ſ ̴١ ߴ.

Ÿ ǸŸ ϴ 罺 忡 ȣ . 罺 78.65% Ʈũ ȸ Ѵ. 200 Ѵ ̱̿뼺ȸ ǴϾ𸮴(KOL) ȸ.

ü 罺 Ʈ ũ(Strathspey Crown) պǴ 豸 . ؿ 忡 ҿ ο ޵ÿƽ(ڱδ) 忡 Ǻ, ܰ о Ʈũ ħ ̴ ⿩ ̶ м ´.

  罺 ֺ 2019 ֿ (ó: ۷ ǥ)

߿ SK̿ ž FDA 㰡

ش Ǿǰ ߰ FDA 㰡 ҽĵ ̾ ȴ.

SK̿ 11 ̱ǰǾ౹(FDA) ġĺ 'ٸƮ(Cenobamate)' ɻ簡 ۵ƴٰ 7 . FDA ٸƮ 㰡 θ 11 ̴.

ٸƮ SK̿ ڰ ž ĺ̴. SK̿ Ϲ̡ƽþơ߳  2400 ӻ ̱ SK̾𽺸 ž㰡 ûߴ. ٸƮ FDA ް Ǹ ߰ ž ó ̱ ϰ ȴ.

SK̿ ž ָ FDA 㰡 ´. SK̿ ָ ӻ1 Ϸ 2011 ĸƼ ߴ.

ָ ۷ι ӻ3 2017 12 FDA ָ 㰡û ߴ. 12 ָ FDA 㰡 ΰ ǰ ̾ FDA Ⱓ 3 ߴ.

ѹ̾ǰ ȣ߱ġ ѷƼ FDA 㰡 ɼ ִ.

ѹ̾ǰ Ʈʻ ƮĸƼ 1227 FDA ѷƼ Ǿǰ 㰡 û(BLA) Ϸߴ.

ѷƼ ȣ߱ ġ ȿ ð ø ̿ž̴. ̿Ǿǰ ȿ ӽð ÷ִ ѹ̾ǰ Ŀ ƴ. ѹ̾ǰ 2012 Ʈ ѷƼ ߴ. Ʈ 2015 ѷƼ ӻ3 ߰ ߴ.
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    رŸ ϸ ڿ ֽʽÿ. ּҴ dailypharm@dailypharm.comԴϴ.

ֽż ݴ
  • 2019.02.09 16:49:06 |

    ׷ٰ

    žళѴٰ ż 㰡ش޶ Ҹ ô.

    0 1 0
ٺ Ϲݾ ǸŰ (2024 05)
౹ 71
ǰ ְ
ѽŻ÷(10) 3,500 2,300 1,200 3,028
޾(100) 25,000 22,000 3,000 23,304
Ʒγΰ(100) 30,000 27,000 3,000 29,237
īɾ(10g) 8,000 5,500 2,500 6,472
Ľõ򿬰(5g) 5,500 4,000 1,500 5,035
Ź(4) 5,000 3,500 1,500 4,449
ڶ(20) 7,000 5,800 1,200 6,433
(10) 6,000 4,000 2,000 4,914
Ժ(10) 4,000 3,000 1,000 3,543
ڱ׸(20) 5,000 3,800 1,200 4,622
ť(10) 3,500 2,300 1,200 2,828
Ȱť(1) 1,200 1,000 200 1,140
Ǯɾ(3.3ml) 25,000 22,000 3,000 24,214
޵𿬰(10g) 7,000 5,000 2,000 6,162
öŸ(34) 13,000 10,000 3,000 12,089
뽺ī(20g) 22,000 18,000 4,000 20,358
ġ(1) 1,100 1,000 100 1,000
ӽ÷(21) 10,000 7,500 2,500 8,998
ͺ(10) 3,500 2,300 1,200 3,138
ݿ(1ڽ) 3,000 2,500 500 2,947
׶÷糪ƮŸ(6) 8,000 7,000 1,000 7,973
߽Ÿ(120) 70,000 40,000 30,000 54,203
Źĸ(10ĸ) 3,000 2,000 1,000 2,941
Ÿ̾(120) 60,000 40,000 20,000 49,168
տ(60ĸ) 30,000 24,000 6,000 27,235
Ÿ̷ER(6) 2,500 2,500 0 2,500
ٿ(30g) 12,000 9,000 3,000 11,221
(120) 25,000 18,000 7,000 21,716
Ʒ(6) 4,000 3,000 1,000 3,509
ǽõĸ(270ĸ) 120,000 85,000 35,000 106,875
B(120) 70,000 60,000 10,000 62,308
׳(10) 3,000 2,000 1,000 2,684
6̺(10) 3,500 2,000 1,500 2,965
(60) 250,000 200,000 50,000 224,000
Ⱦ 12,000 9,000 3,000 10,494
̰źĸ(60ĸ) 25,500 22,000 3,500 23,942
Ųť(20) 5,500 4,500 1,000 4,823
λ絹÷(100) 37,000 29,000 8,000 31,878
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