Nang Kuang Pharmaceutical Co. Ltd.

05/26/2022 | Press release | Distributed by Public on 05/26/2022 01:05

Nang Kuang Pharmaceutical Co., Ltd. has received final U.S.FDA approval for its ANDA.

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Provided by: NANG KUANG PHARMACECUTICAL CO., LTD
SEQ_NO 1 Date of announcement 2022/05/26 Time of announcement 14:53:41
Subject 
 Nang Kuang Pharmaceutical Co., Ltd. has received
final U.S.FDA approval for its ANDA.
Date of events 2022/05/26 To which item it meets paragraph 51
Statement 
1.Date of occurrence of the event:2022/05/26
2.Company name:Nang Kuang Pharmaceutical Co., Ltd.
3.Relationship to the Company (please enter "head office" or
  "subsidiaries"):Head Office
4.Reciprocal shareholding ratios:Not Applicable
5.Cause of occurrence:The Abbreviated New Drug Application (ANDA)
for Pemetrexed for Injection indicated for the treatment of lung
cancer has been final approved by the U.S. Food and Drug
Administration (FDA).
6.Countermeasures:The drug will be immediately launched in the
U.S. to increase the revenue.
7.Any other matters that need to be specified:
The ANDA for Pemetrexed for Injection indicated for the treatment of
lung cancer has been reviewed and approved by the FDA.