The Food and Drug Administration (FDA) approved the first generic drug under a new approval pathway today.
FDA Approves First Generic Drug Under New Approval Pathway
The FDA granted approval of potassium chloride oral solution USP to Apotex Inc., a global pharmaceutical company that produces both generic and novel drugs. Potassium chloride is an oral treatment for patients at risk for low potassium blood levels. Importantly, the products approved today are the first generics to receive a Competitive Generic Therapy (CGT) designation. Also notable, the drug application received approval during the first review cycle. The following two potassium chloride oral solutions are approved:
- Potassium chloride oral solution USP, 10% (20 mEq/15 mL) and
- Potassium chloride oral solution USP,20% (40 mEq/15 mL).
What is a Competitive Generic Therapy Designation?
The Reauthorization Act of 2017 gives the FDA authority to name a drug as a Competitive Generic Therapy if there is inadequate generic competition for that drug. The CGT designation is a new drug approval pathway. The FDA’s use of CGT is a strategy to speed up the development and review of generic drug products. Further, the aim of CGT is increasing competition in the generic drug market.
Inadequate Generic Competition
Inadequate generic competition means ‘that not more than one approved drug in the active section of the publication Approved Drug Products with Therapeutic Equivalence Evaluations’ exists. The Approved Drug Products with Therapeutic Equivalence Evaluations publication is popularly called the Orange Book. The Orange Book identifies drug products approved by the FDA based on safety and effectiveness.
FDA Competitive Generic Therapy Designation: Terms and Conditions
The accelerated implementation of CGT is part of the FDA’s plan to lower the amount of money Americans pay for medicine.
Today’s approval marks the successful implementation of a new program designed to encourage generic drug development for products with inadequate generic competition. FDA Commissioner Gottlieb
The FDA wants to increase competition in the generic drug market. On top of that, the FDA wants to cut drug prices. Accordingly, the CGT approval pathway reduces the time it takes for generic drugs to reach the market. CGT lessens the required drug review cycles during drug review processes. The following provides important information about the CGT designation. Note: bulleted text taken directly from today’s press release.
- Applicants for drugs that receive a CGT designation may receive review enhancements and expedited review of their Abbreviated New Drug Applications (ANDA).
- Applicants for drugs that receive a CGT designation are also eligible for a 180-day period of marketing exclusivity if they are the first approved applicant for that CGT and meet certain other conditions.
- Under a special forfeiture rule for CGTs, the applicant must commercially market the CGT within 75 days after the date of approval of its ANDA or it will forfeit its exclusivity.
- The agency requires ANDA applicants to demonstrate that all aspects of their drug product meet the FDA’s rigorous approval standards that ensure an equivalent, high quality, safe and effective generic medicine.
- As with brand-name drugs, the FDA reviews manufacturing and packaging facilities for generic drugs to ensure they are capable of consistently producing quality products.
The FDA also approved a new cancer treatment today.