HBW Insight 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

CAGR For OTC Switch Forecast At 5%, But Without Statins, Asthma Treatments

This article was originally published in The Tan Sheet

Executive Summary

OTC switch product sales are estimated to grow at a compounded annual growth rate of 5% by 2019, with opportunities likely emerging in bladder control for women and sleep aids, according to Kline Market Research. But asthma drugs and statins are not likely to debut OTC soon, notes analyst Laura Mahecha.

You may also be interested in...



Before Asking FDA For Novel OTC Switch, Be Sure DFL Alone 'Can't Get There'

"You need to demonstrate to the best of your ability that you can't get there with just the Drug Facts label," says ONDP Director Theresa Michele during presentation on the FDA office' work over the past year at Consumer Healthcare Products Association's annual regulations and science conference.

Merck Singulair Switch NDA Limits Indication to Allergies, Omits Asthma

Merck will try to convince an FDA advisory committee May 2 to partially switch its blockbuster Rx drug Singulair to OTC for allergy relief in adults only. The firm will not seek to switch the Rx indications for asthma or allergy relief in children.

Adulturated red yeast rice

FDA threatens enforcement action against two firms selling red yeast rice supplements adulterated with lovastatin - the active ingredient in Merck's Rx cholesterol-lowering drug Mevacor. Consumers should not purchase or consume Swanson Healthcare Products' Red Yeast Rice and Red Yeast Rice/Policosonal Complex or Sunburst Biorganics' Cholestrix since FDA testing revealed the presence of the statin, which can cause harmful side-effects such as muscle weakness and kidney issues and may interact with other medications, FDA announces Aug. 9. The agency determined the adulterated supplements are unapproved new drugs, sent warning letters to the companies marketing the products and threatens to employ enforcement actions, such as seizure of illegal products and criminal prosecution if the companies fail to resolve the violations immediately, according to the warning letters. In January 2005, Source Naturals received a courtesy letter from FDA for the same problem (1"The Tan Sheet" Jan. 24, 2005, In Brief)...

Topics

Related Companies

UsernamePublicRestriction

Register

RS123437

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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