Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Omni Nutraceuticals

This article was originally published in The Tan Sheet

Executive Summary

Inholtra Joint Pain analgesics with glucosamine and chondroitin are monograph compliant despite FDA concerns about OTC/supplement combination products, Omni says. A launch date has not been set for the line of four analgesics (aspirin, acetaminophen, ibuprofen and naproxen sodium ) and the company is still in talks with FDA regarding labeling. Omni says the products differ from other combinations because they will be labeled only with OTC indications, claims and dosing schedules approved under existing monographs, not structure/function claims. FDA recently sent letters discouraging several companies from marketing products with both OTC and supplement claims, and promised future guidance on the issue (1"The Tan Sheet" June 12, p. 3). Omni will list glucosamine and chondroitin as "inactive ingredients" on labeling but will prominently display them on packaging, relying on consumers' knowledge of the ingredients
Advertisement

Related Content

OTC/Supplement Combo New Safety/Efficacy Data Not Needed - Attorney Hutt
OTC/Supplement Combo New Safety/Efficacy Data Not Needed - Attorney Hutt
OTC/Supplement Combo New Safety/Efficacy Data Not Needed - Attorney Hutt
Omni Voluntarily Modifies Inholtra Ads Following NAD Review
Omni Voluntarily Modifies Inholtra Ads Following NAD Review
Omni Voluntarily Modifies Inholtra Ads Following NAD Review
Omni Nutraceuticals
Omni Nutraceuticals
OTC/Supplement Combinations "Serious Concern" For FDA
OTC/Supplement Combinations "Serious Concern" For FDA

Topics

Advertisement
UsernamePublicRestriction

Register

PS091410

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel