Covalent Medical

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your FOCUS PI Post-Injection Eye Drops product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).

Passage 2

your FOCUS PI Post-Injection Eye Drops drug product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because this product is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.

Passage 3

the statements made in your product labeling on your website and social media sites include claims for relief of post-injection irritation, which are not permitted indications for ophthalmic demulcent drug products in monograph M018.