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
- CGT applicants are also eligible for a 180-day period of marketing exclusivity if they are the first approved applicant among other conditions.
- Ref: US FDA | Image: News Wire
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