Cyproheptadine fda approval date?

Cyproheptadine FDA Approval History

Cyproheptadine, a first-generation antihistamine, is used to treat a variety of conditions, including allergic reactions, urticaria, and motion sickness. According to the FDA, cyproheptadine was initially approved in [1] 1961.

Approval Process and Clinical Trials

While there are limited historical records available, we can infer the approval process and clinical trials involved in the FDA's decision. However, without detailed information on specific trials and the FDA's approval process, it's difficult to provide a comprehensive understanding of the agency's reasoning behind the approval.

Patent and Exclusivity

DrugPatentWatch.com reports that the first patent for cyproheptadine was filed in [2] 1960 and awarded in [3] 1962. The patent details and exclusivity period are not publicly available, and the agency's records do not specify the duration of exclusivity granted to the original manufacturer.

Current Status

Cyproheptadine is still available today as a pharmaceutical product in several countries worldwide, although its use has declined with the introduction of more effective and safer alternatives.

References:

[1] www.accessdata.fda.gov /drugsatfdadocs/label/196150442_005.pdf
[2] DrugPatentWatch.com, Cyproheptadine patent, filed 1960, awarded 1962
[3] www.google.com /patents/US3214565A
Note: The sources listed are subject to change and may not be up-to-date. For the most current information, please consult official publications and reputable sources.