Two Rx-to-OTC allergy switches approved by FDA

In a clear sign of a more favourable attitude to Rx-to-OTC switch, the US FDA last week approved two new allergy products for non-prescription use.

Lastacaft alcaftadine ophthalmic 0.25% solution (Allergan / AbbVie) is now available without a prescription online and in retail stores for individuals aged 2+ years with ocular allergies. As demonstrated in clinical studies, one drop works in as little as three minutes to provide relief from itchy eyes for up to 16 hours. Following the recent FDA Rx-to-OTC switch approval, the original patented prescription-strength formulation of Lastacaft is available in a 5ml multidose bottle containing a 60-day supply, as well as a twin pack with two 5ml multidose bottles.

Perrigo also received final approval last week from the FDA for the OTC use of Nasonex 24HR Allergy (mometasone furoate monohydrate 50mcg). This marks the first branded Rx-to-OTC switch for the company, which expects to begin offering the nasal spray later this year. Nasonex is a registered trademark of Organon and is used by Perrigo and its affiliates under licence.

Nicholas Hall’s Touchpoints: This development will no doubt lead to an increase in switch activity after House and Senate committee members cited concerns that “very few products in recent years have switched from prescription drugs to nonprescription drugs” and pointed out that the FDA is expected to “meet the goals of the Fall 2021 Unified Agenda and publish and subsequently finalise the proposed rule titled Nonprescription Drug Product with an Additional Condition for Nonprescription Use.”

The appropriations committees are also: “Concerned about dietary supplement products that are adulterated or misbranded, in particular with imported products. The agreement provides an increase of US$2mn in the FDA’s budget [US$6.1bn in total] to be used for inspections, as well as enforcement of the Dietary Supplement Health & Education Act of 1994”. My sense is that in the biggest market for both switch and dietary supplements, we could see a correction in the prevailing trend from treatment to prevention.

Take a look at the latest CHC innovations in our forthcoming 2022 edition of Innovation in CHC from CHC New Products Tracker. This report offers a look at Rx-to-OTC switch activity, as well as innovation by region, marketer and 20 individual countries. To pre-order your copy and save up to £1,350 with the pre-publication discount, or for further information on this report, please contact melissa.lee@NicholasHall.com.

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