Drug Approval | April 17, 2024
GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA
Submission based on results from pivotal phase III trial showing all primary endpoints met
Submission based on results from pivotal phase III trial showing all primary endpoints met
SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva
The product will be manufactured at Lupin’s Nagpur facility in India
The inspection classification was determined by the agency as Voluntary Action Indicated
Norgestrel and Ethinyl Estradiol Tablets USP (RLD Lo/Ovral-28) had an estimated annual sale of USD 34 million in the U.S. (IQVIA MAT Mar 2023)
The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.
The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
Mirabegron Extended-Release Tablets, 25 mg and 50 mg, had estimated annual sales of US $2.4 billion in US
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
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