DULAC FARMACEUTICI · 66-41 · ITALY

Product code, Product and FDA notes

45 C - - 99 Antioxidants (Food Additives for Human Use) Date Published: 09/17/2024 Desc: Diosmin Expert Omniven 500 Notes: The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 53 L - - 99 Other Skin Care Preparations, N.E.C. Date Published: 09/20/2024 Desc: Diosmin Expert Omniven Gambe Notes: The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 09/17/2024 Desc: Diosmin Expert Omniven 500 Notes: The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 09/17/2024 Desc: Diosmin Expert Omniven 500 Notes: The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)]. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 09/20/2024 Desc: Diosmin Expert Omniven Gambe Notes: The product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Therefore, the article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug and Cosmetic Act (the Act) in that it appears to be a new drug within the meaning of Section 201(p) of the Act without an effective new drug application (NDA) [Unapproved New Drug, Section 505(a)].