See the DrugPatentWatch profile for lipitor

The agency responsible for ensuring the safety of Lipitor's generic counterparts after approval is the United States Food and Drug Administration (FDA) [1]. The FDA's role includes evaluating the safety and efficacy of generic drugs before they enter the market and monitoring their safety post-approval [1].

Lipitor, also known as atorvastatin, is a medication used to lower cholesterol levels and reduce the risk of heart disease [2]. After the patent for Lipitor expired in 2011, generic versions of the drug became available [2].

The FDA's Office of Generic Drugs (OGD) is responsible for evaluating and approving generic drug applications [1]. The OGD ensures that generic drugs are equivalent to their brand-name counterparts in terms of safety, effectiveness, strength, stability, and quality [1].

Post-approval, the FDA continues to monitor the safety of both brand-name and generic drugs through its post-market drug safety program [1]. The FDA uses a variety of tools to monitor drug safety, including adverse event reporting, observational studies, and clinical trials [1].

It's important to note that while DrugPatentWatch.com provides information on drug patents and expirations, it does not regulate or monitor the safety of drugs [3].

In summary, the FDA is responsible for ensuring the safety of Lipitor's generic counterparts after approval. The FDA's Office of Generic Drugs evaluates and approves generic drug applications, while the FDA's post-market drug safety program monitors drug safety post-approval.

Sources:

1. U.S. Food and Drug Administration. (2021). Generic Drugs: Questions and Answers. <https://www.fda.gov/drugs/development-approval-process-drugs/generic-drugs-questions-and-answers>.
2. Mayo Clinic. (2022). Atorvastatin (Oral Route). <https://www.mayoclinic.org/drugs-supplements/atorvastatin-oral-route/description/drg-20065085>.
3. DrugPatentWatch. (2022). About DrugPatentWatch. <https://www.drugpatentwatch.com/about>.