OTC COMBINATION PRODUCTS
Each of the following ingredients is in the OTC monograph as an immediate release drug: dextromethorphan, diphenhydramine and phenylephrine.
The Combination OTC monograph permits the following combinations of the above ingredients:
Dextromethorphan + diphenhydramine
Dextromethorphan + phenylephrine
Diphenhydramine + phenylephrine
Dextromethorphan + diphenhydramine + phenylephrine
Historically, the FDA has allowed long acting formulations of these drugs to be created with pharmacokinetic only trials.
Therefore, it is the Cough Company’s goal to create each of the above combinations as twice a day, BID, formulations using our proprietary REA Ion Exchange Resin™ drug delivery platform.
These would be 505(b)(2) NDAs and each would be eligible to have our patents listed in the Orange Book to provide long term protection against store brands.
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