Area of focus

OTC Drugs and Cosmetics

There is a myriad of issues to consider when designing, manufacturing, and promoting over the counter (OTC) drugs. Particularly when marketing your OTC drug, significant attention must be paid to the wording on your product’s label.

Our broad experience with drug companies has resulted in a sophisticated...

Representative experience

Analyzed and advised on OTC switch strategies for lipid-lowering and heartburn drug products for top-tier pharmaceutical companies.

Assisted an OTC drug manufacturer on developing and launching two new products, a topical analgesic and an antifungal, including reviewing the product labeling, website content, and other promotional materials and activities.

Assisted an OTC drug manufacturer on developing and launching two new products, a topical analgesic and an antifungal, including reviewing the product labeling, Web site content, and other promotional materials and activities.

Prepared an in-depth analysis for a client with a significant stake in the Plan B® debate, on the FDA’s authority to restrict a drug to behind-the-counter (BTC) status.

Advised a client on regulatory risks associated with novel dosage forms under the OTC monograph system and anticipated changes under the OTC drug monograph reform legislation.

Advised an influenza drug product’s sponsor on strategies for regulatory approval of OTC epidemic and pandemic kits.

Advised OTC cough/cold products marketers on potential changes to pediatric dosing information in light of safety concerns.

Counseled large retailers on implementing adverse event reporting requirements for OTC drug monograph products.

Conducted due diligence for a client acquiring an OTC insecticide product.


Conducted due diligence for medium-size OTC drug manufacturer acquiring another medium-size OTC drug manufacturer.

Assisted the developer of a new labeling format that enables the provision of weight-based pediatric dosing Information for OTC drug products within the Drug Facts labeling format.

Evaluated the regulatory status of long-marketed “legacy” OTC drug products for purposes of price reporting and assessing the risks of continued marketing.

Reviewed a new advertising campaign for OTC cough/cold products.

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