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New Jersey business planning: Merck takes a risk with Oxytrol

The New Jersey based pharmaceutical giant Merck is seeking FDA approval to switch Oxytrol to an over-the-counter medication. The company's business planning led them to take a gamble and purchase the nonprescription drug from Watson Pharmaceuticals Inc. Merck believes that the patch would be a good over-the-counter alternative to oral medications since there are fewer side effects.

The Federal Drug Administration, or FDA, is unsure that Merck has shown that the drug, manufactured for women with bladder control issues, can be used safely in the absence of a prescription. Research has shown that some women failed to correctly determine whether they should use the patch and some men used the patch despite the fact that the product is labeled for women only. Despite these pitfalls, FDA sources indicate that they don't believe Oxytrol will need any safety precautions in addition to existing warnings.

The FDA has indicated that it should make its decision by the end of January 2013 regarding whether Oxytrol can be sold over-the-counter. FDA regulations state that any medication that is determined to be suitable for over-the-counter use should be sold over-the-counter. The FDA is considering expanding its list of medications that can be sold over-the-counter for chronic conditions such as high cholesterol, high blood-pressure, migraine and asthma. Making medications for these conditions more readily available to the general public without a prescription could ease the financial burden many feel when it comes to treating these ailments.

Taking risks is part of any successful New Jersey company's business planning. Approximately five years ago, Merck began studying Oxytrol. The company believes that Oxytrol would benefit millions of women who are dealing with bladder control issues if the medication was allowed to be sold over-the-counter. It is estimated that up to 80 percent of all women with this condition have not sought the advice of a doctor. Even though Merck will still make money on Oxytrol if it remains a prescription drug, the company stands to make even more money should the medication be sold over-the-counter.

Source:, "FDA unsure whether Merck's patch for bladder control, Oxytrol, ready for OTC," Nov. 8, 2012

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