Rx-to-OTC Switch

Glenmark acquires a portfolio of generic OTCs from Wockhardt marketed in US including famotidine 10- and 20-mgs; cetirizine 5- and 10-mgs; lansoprazole 15-mg delayed-release; and olopatadine hydrochloride 0.1% ophthalmic solution.

FDA’s “Additional Condition for Nonprescription Use” proposal is all about information which won’t be printed on DFLs but will be integral to whether some switch proposals’ approval. But agency doesn’t explicitly exclude switch sponsors from assigning delivery of ACNU information to staff in stores or in online chats.

From intranasal corticosteroids to a lice treatment, and from an addition to the OTC PPI market to the first nonprescription acne drug reaching the market through an NDA, US OTC switches in the past 10 years, since FDA began considering widening switch opportunities, haven’t lacked for variety.

OTC drug development and marketing consultants discuss FDA allowing simultaneous Rx and OTC sales of same drug formulation with the same indication and about opportunities for follow-on generic equivalents of switches approved as additional condition for nonprescription use OTCs.

In this episode, HBW Insight speaks to Victoria Nichols, project director of Free the Pill, a campaign supporting increased OTC oral contraceptive access in the US. In the wake of the Supreme Court’s decision to overturn Roe v. Wade on 24 June, Nichols discusses the importance of advocating for OTC birth control, the limited availability of OTC oral contraceptives in the US, and the current legislation being introduced that would help ensure OTC birth control is covered by insurance. 

OTC drug development and marketing consultants spoke with HBW Insight about FDA’s “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” proposed rule. In first of two articles, they discuss proposed rule’s likely impacts on industry and remaining concerns around incorporating extra-label information in drug labeling.

“Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for some OTC switches. Along with NDAs, sponsors would need to show a DFl isn’t sufficient to ensure a consumer can appropriately self-select and use a drug OTC and how an “additional condition” system would work.

Publication of "ACNU" proposed rule wasn’t reached in straight line and featured coining another term with more of a regulatory sound, “NSURE,” and detours on explaining where the agency wouldn’t steer OTC drug manufacturing and marketing.