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Dailypharm

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K- ι° ̱ Լ ִ
2024-03-04 05:50:41
K- ι° ̱ Լ ִ
2024-03-04 05:50:41

FDA, Ƽ ǰ㰡 Ÿ ̾ ι°

, 2021 3 С'23'

Ƹ޸ī Ǹš޵彺 ̱ ITC Ҽ
[ϸ= ] 'Ƽ(Letybo)' ǰδ ° ̱ ǰǾ౹(FDA) Ѿ. 2021 3 踦 ° ǰ㰡 û  .

ǸŴ ۷ι Ʈʻ Ƹ޸ī Ѵ. 6 Ը ϴ ִ 忡 ǸŰ ȭ Ǵ , 迡 Ÿ ʸ 500 ̻ ⵵ ̶ ´.

Ƽ, 㰡 û 3 FDA ǰ㰡 ȹ

4 迡 FDA 29(ð) Ȩ Ƽ ǰ㰡 ߴ. 'ߵ~ ָ̰ '̴.


߿ ° FDA ǰ㰡. ռ 2019 2 Ÿ(̱ ǰ ֺ) ǰ㰡 ִ.

Ÿ ̱ FDA εȴ. 2021 3 Ƽ ǰ㰡 û ߴ. ׷ ̵ 2022 3 FDAκ Ͽ䱸(CRL) ޾Ҵ. FDA ȯ ͸ .

10 FDA ° û ߴ. 6 2023 4 ٽ Ͽ䱸 ޾Ҵ. ٸ ߴ Ե ˷.

10 ° ´. FDA ߰, ᱹ 29 ǰ㰡 ޴ ߴ. 忡 23 FDA Ѵ ̴.

ȸ 'Ƹ޸ī' ڸ η Ȯ ä

'Ƹ޸ī(HUGEL AMERICA)' ִ Ѵٴ ħ̴. 迡 ̱ Ը 2022 477000 ޷( 63700) ߻Ѵ.

2018 8 ̱ Ƹ޸ī ߴ. ۷ι Ʈʻ ũθĸ(CROMA-PHARMA GmbH) ̱ ȸ ũθUSA ȸ縦 ߴ.

3 Ƹ޸ī ڿ ϴ 500 ϸ鼭 70% 76.9% Ȯߴ. 9 ũθ ֽܿ θ ϸ 100% ȸ ȯߴ. Ƹ޸ī Ȯ ̱ȣ֡ij ű ̱ η ̶ ִ. ̱ ߽ ijٿ ȣ Ȯ ȴ.


ռ ̱ Ÿ ܿ 1470 ÷ȴ.  ⿡ ߻ 80% 1180 Ѵ. Ϲ̽ ݰ̶ ϸ, 500~600 Ϲ̽忡 ߻ ȴ. 迡 ܱ ̱ ǥ ̿ ̶ м ´.

޵彺 ITC Ҽ 6 ̱ Ǹ

޵彺 ѷ ۷ι Ҽ̴. Ҽ Ƽ ̱ ԡǸű ġ ִ.

޵彺 2022 3 Ƹ޸ī ̱ ȸ(ITC) ߴ. ֿ ߴٴ . ITC 2022 5 縦 ߴ.

޵彺 ǿ Ḧ ûߴ. ޵彺 Ǻΰ 뿡 κп ֵ ̰ ûߴٰ ߴ. , θ Ǵ ǰ ð ϰڴٴ ǵ Ǯ̵ȴ.

ITC ̹ Ҽ ǰ 6, ǰ 10 ´. ̸ ݱ ȿ Ƽ ̱ Ǹ ׷ ȴ.

ռ ó 簡 Ƿ ɼ . ޵彺 ռ ۷ι ִ. 2019 1 ޵彺 ҷ ۵ 2021 2 ޵彺 ޵彺 Ʈʻ ٷ( ֺ), Ʈʻ 罺 3 Ƿ ƴ. ķ ޵彺 ٷ ̱ Ÿ Ǹš Ǹ 罺 οߴ. 罺 DZݰ Բ ⿡ οƼ ޵彺ٷ Ѵ.
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ֽż ݴ
  • 2024.03.04 06:29:44 |

    Itc report

    VII. CONCLUSION For the reasons set forth above, the Staff does not expect the evidence to show a violation of Section 337 by Respondents by reason of theft or conversion.

    0 0 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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