Pink Sheet is part 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

Pancold A elicits FDA warning

This article was originally published in The Tan Sheet

Executive Summary

B&A Health Products' multi-symptom relief liquid OTC is an unapproved new drug because it does not conform with the final monograph for Cold, Cough, Allergy, Bronchodilator and Antiasthmatic Drug Products. The agency says Pancold A does not satisfy monograph requirements because it includes noncompliant ingredients, such as anhydrous caffeine and di-methylephedrine hydrochloride, according to an Aug. 19 letter to the Santa Fe Spring, Calif., firm. FDA also says several indications contravene the monograph, including a claim the product is a "sneeze suppressant." Finally, FDA warns, the drug's packaging does not bear the Drug Facts labeling required of OTC drugs

You may also be interested in...



Health Sector On High Alert As Wuhan Coronavirus Spreads

The latest figures from China's National Health Commission show infections of the new Wuhan coronavirus are continuing to pile up, spreading to more cities in the country and abroad as travel for the Lunar New Year festival goes into high gear. Meanwhile, the Chinese government maintains that the situation is “preventable and controllable.”

OTC Drug Oversight By US FDA Split Among Two Divisions In Reorganization

CDER Office of New Drugs changes its organization including establishing Office of Nonprescription Drugs and splitting the office into Division of Nonprescription Drug Products I and DNDP II. A Division of Regulatory Operations for Nonprescription Drugs will be comprised of regulatory staff from the ONPD divisions and will report to OND’s regulatory office. Non-clinical ONPD staff will report to the office director.

Verrica Ready To Target Pediatric Dermatologists With First Molluscum Therapy

Anticipating a July approval of its cantharidin formulation, Verrica says it is poised to implement a buy-and-bill model for a clinician-administered product with an addressable market of 6 million.

Topics

UsernamePublicRestriction

Register

PS104519

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