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Viwit's Nitroglycerin Sublingual Tablets Approved by FDA

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Viwit's Nitroglycerin Sublingual Tablets Approved by FDA

  • Categories:In 2024
  • Author:VIWIT
  • Origin:
  • Time of issue:2024-10-22 14:48

(Summary description)Recently, Viwit Pharmaceuticals' proprietary developed Nitroglycerin Sublingual Tablets (strengths: 0.3 mg, 0.4 mg, 0.6 mg) received a marketing authorization letter from the US Food and Drug Administration (US FDA), ANDA number: 218583, signifying the product's official approval in the US market.

Viwit's Nitroglycerin Sublingual Tablets Approved by FDA

(Summary description)Recently, Viwit Pharmaceuticals' proprietary developed Nitroglycerin Sublingual Tablets (strengths: 0.3 mg, 0.4 mg, 0.6 mg) received a marketing authorization letter from the US Food and Drug Administration (US FDA), ANDA number: 218583, signifying the product's official approval in the US market.

  • Categories:In 2024
  • Author:VIWIT
  • Origin:
  • Time of issue:2024-10-22 14:48
  • Views:
Information

Recently, Viwit Pharmaceuticals' proprietary developed Nitroglycerin Sublingual Tablets (strengths: 0.3 mg, 0.4 mg, 0.6 mg) received a marketing authorization letter from the US Food and Drug Administration (US FDA), ANDA number: 218583, signifying the product's official approval in the US market. 

Nitroglycerin Sublingual Tablets are primarily used to prevent and rapidly relieve angina pectoris caused by coronary artery disease. Nitroglycerin Sublingual Tablets dissolve quickly under the tongue, taking effect within 2-3 minutes, reaching peak levels within 3-5 minutes, with a bioavailability of up to 80%. The medication is stable and long-lasting, assisting clinicians save more patients' lives and effectively improve their quality of life. 

Viwit Pharmaceuticals submitted the ANDA for Nitroglycerin Sublingual Tablets to the US FDA in December 2023 and officially received approval in October 2024. The rapid approval of the Nitroglycerin Sublingual Tablets within 10 months is a testament to Viwit Pharmaceuticals R&D team’s commitment to QbD (Quality by Design), the regulatory registration team’s implementation of SbR (Science-based Response), the supply chain team’s ability to procure raw and auxiliary materials in compliance with both Chinese and US regulations, the clinical team’s coordination of various domestic and international clinical trials, the quality assurance, quality control, and production management teams’ adherence to GMP in daily operations, and the  business team’s capability in international business development.

The approval of Nitroglycerin Sublingual Tablets in the United States marks another significant and meaningful milestone for the company. This approval provides more medication options for patients, enriches the company's product pipeline, and enhances the company’s core competitiveness. In the future, Viwit Pharmaceuticals will continue to focus on drug R&D and production, brand building, channel marketing, and social responsibility, fully leveraging its influence in the global pharmaceutical market and its social responsibility!

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