Mar 13, 2025 · Explore the FDA’s Competitive Generic Therapy Approvals page, offering insights into the program designed to encourage generic drug competition. Access information about approved CGT products...

FDA may designate a drug as a CGT after determining that there is inadequate generic competition for that drug. The term inadequate generic competition is defined to mean, with

FDA recently issued a draft guidance on CGTs to provide generic drug applicants with information on how to request a CGT designation and whether they may be eligible for CGT exclusivity....

Jul 23, 2024 · The Office of Generic Drugs updated its list of the Competitive Generic Therapy (CGT) designation products that have been approved to date . There have been 312 products granted this designation since the start of the program, with the first application approved to gain CGT 180-day exclusivity under 506H of the Federal Food, Drug, and Cosmetic ...

Feb 15, 2019 · The US Food and Drug Administration (FDA) on Friday released draft guidance providing information on how sponsors can apply for competitive generic therapy (CGT) designations and when they may be eligible for CGT exclusivity.

Apr 17, 2024 · As most in the biotech industry know, cell and gene therapies (CGT) are regulated in the U.S. as biological products by FDA’s Center for Biologics Research and Evaluation (CBER) and require approval of a biologics license application (BLA) under Section 351 of the Public Health Service Act, prior to being marketed.

May 14, 2020 · The US Food and Drug Administration (“FDA”) recently issued a final guidance on the Competitive Generic Therapies (“CGT”) program. The CGT program created a new pathway by which the FDA may designate a drug with “inadequate generic competition” as a CGT.

Feb 21, 2025 · What This Means for Cell and Gene Therapy (CGT) Developers. FDA’s draft guidance highlights a collaborative approach to CGT product development, encouraging sponsors to engage early and invest in robust CMC, nonclinical, and clinical strategies.

Feb 21, 2019 · The FDA Reauthorization Act of 2017, or FDARA, created a new pathway by which FDA may, at the request of an ANDA applicant, designate a generic drug candidate as a CGT.

Jun 3, 2020 · Under this new pathway [new Section 506H of the Federal Food, Drug, and Cosmetic Act (FDC Act)], FDA may, at the request of an applicant, designate a drug with “inadequate generic competition” as...