First Generic approved by FDA using Competitive Generic Pathway (CGT) to Foster Competition for sole source drugs

 First Generic approved by FDA using Competitive Generic Pathway (CGT) to Foster Competition for sole source drugs

First Generic approved by FDA using Competitive Generic Pathway (CGT) to Foster Competition for sole source drugs

Shots:
 
  • The FDA granted approval of potassium chloride (KCl) oral solution USP to Apotex
  •  KCl’s used is used to treat hypokalemia in patients on diuretics
  •  Under FDARA 2017, a drug with inadequate generic completion is given CGT designation, CGT applicants may receive expedited review ANDA
o   CGT applicants are also eligible for a 180-day period of marketing exclusivity if they are the first approved applicant among other conditions
 
Click here to read full press release/ article | Ref: US FDA | Image: News Wire

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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