Over The Counter (OTC) Drug News and Research

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Mylan announces FDA approval for Cetirizine Hydrochloride tablets

Mylan Inc. has announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets (OTC), 5 mg and 10 mg.

2 Jan 2008

FDA extends comment period for proposed sunscreen regulation

The Food and Drug Administration has announced that it will be extending the comment period on the agency's proposed sunscreen regulation to Dec. 26, 2007.

27 Nov 2007

GlaxoSmithKline obtains U.S. OTC marketing rights to MEVACOR (lovastatin) from Merck

GlaxoSmithKline, Philadelphia, PA, USA (GSK) and Merck & Co., Inc., Whitehouse Station, NJ, USA (Merck), announced today that they have entered into an agreement for over-the-counter (OTC) marketing rights for MEVACOR (lovastatin).

27 Nov 2007

Schering-Plough acquires Organon BioSciences

Schering-Plough Corporation has announced that it has completed the acquisition of Organon BioSciences N.V., creating a stronger combined company with broader human and animal health portfolios, an enhanced pipeline and increased R&D capabilities. Schering-Plough's agreement to acquire Organon BioSciences was announced on March 12, 2007.

20 Nov 2007

Hispanics and African Americans are less likely to use commercial weight loss programs

A new analysis of a landmark weight loss survey suggests that Hispanics and African Americans are more likely than whites to use unproven dietary supplements for weight loss.

22 Oct 2007

FDA says OTC cough and cold medicines do not work for young children

The Food and Drug Administration (FDA) in the U.S. are warning parents about the use of over-the-counter (OTC) cough and cold medicines in young children.

22 Oct 2007

Bayer HealthCare clear to acquire Citracal calcium supplements in the United States

Bayer HealthCare (BHC) has announced that its Consumer Care Division has received regulatory approvals necessary to acquire the Citracal line of over-the-counter (OTC) calcium supplements in the United States.

8 Oct 2007

FDA warns Procter and Gamble on hand sanitizer marketing

The U.S. Food and Drug Administration (FDA) has sent a warning letter to Procter & Gamble for making unlawful claims about its Vicks Early Defense Foaming Hand Sanitizer (Early Defense) product.

18 Sep 2007

UVA protection in sunscreens to be shown

The U.S. Food and Drug Administration today proposed a new regulation that sets standards for formulating, testing and labeling over-the-counter (OTC) sunscreen drug products with ultraviolet A (UVA) and ultraviolet B (UVB) protection.

24 Aug 2007

Warning - OTC diet supplement contains undeclared diet drug

Canadians are being warned that an over-the-counter (OTC) dietary supplement has been recalled because it contains a prescription drug used in the treatment of obesity.

21 Aug 2007

FDA says cough and cold products used irresponsibly with children

The Food and Drug Administration (FDA) in the United States says it is concerned that cough and cold products sold over the counter (OTC) are being irresponsibly used particularly with children under the age of two.

20 Aug 2007

Breast feeding mothers warned of risks of Codeine for babies

The Food and Drugs Administration (FDA) in the United States has issued a warning to nursing mothers regarding the pain-killer codeine.

20 Aug 2007

New study looks at over-the-counter (OTC) anti-aging products

Findings from a study released today revealed that a limited amount of clinical research exists to prove the effectiveness of many over-the-counter (OTC) anti-aging products. The study is published in the July/August 2007 issue of the Aesthetic Surgery Journal, the official peer-reviewed journal of the American Society for Aesthetic Plastic Surgery (ASAPS).

13 Aug 2007

Calypte begins U.S. initiative

Calypte Biomedical Corporation has announced that it has leased an 11,000+ square foot site located in Portland, Oregon.

10 Jul 2007

Early diagnosis and prevention of the effects of tooth erosion are fundamental to keeping teeth healthy for life

Fruit, yogurt, citric and soft drinks, may seem like harmless snacks and beverages, but improper consumption and overuse may lead to devastating and permanent damage to teeth. It's known as tooth erosion, the break down of tooth structure caused by the effect of acid on the teeth that leads to decay.

26 Jun 2007

OTC diet pill Alli now on sale in the U.S.

The first and only over-the-counter (OTC) product for weight loss approved by the Food and Drug Administration (FDA) has gone on sale in the U.S.

18 Jun 2007

Does Alli work?

The first and only over-the-counter product for weight loss approved by the Food and Drug Administration will be available Friday, June 15.

17 Jun 2007

Alli weight loss drug on the U.S. market soon

Alli which is produced by GlaxoSmithKline will be available to consumers in America next week following a 150 million dollar advertising campaign to promote the non-prescription drug.

12 Jun 2007

Doctors say too many Brits addicted to OTC drugs

Doctors in Britain are warning about the dangers of becoming addicted to over-the-counter (OTC) medicines; they say more research is needed on how many misuse OTC drugs.

7 May 2007

Novagali Pharma announces FDA clearance of trial for treatment of dry eye syndrome

Novagali Pharma has announced that the Company's Investigational New Drug Application (IND) to conduct a pivotal Phase III clinical trial of its Cyclosporine A ocular product, Nova22007, has been granted by the U.S. Food and Drug Administration (FDA).

27 Apr 2007