1. HBW Insight
  2. >>Health
  3. >>Rx-to-OTC Switch

OTC Allergy Switch Approved For Bayer In US

Azelastine 0.15% Nasal Antihistamine Branded Astepro Allergy Is First-In-Class Switch

 
• By Malcolm Spicer

CDER approves Bayer Healthcare’s azelastine 0.15% nasal antihistamine indicated for seasonal and perennial allergic rhinitis in adults and children 6 and older. Bayer says Astepro Allergy is first steroid-free antihistamine for allergies available OTC in the US and the first indicated for indoor and outdoor allergy relief.

Bayer AG adds a brand to its US OTC allergy remedy lineup as the Food and Drug Administration adds a first-in-class ingredient to the products it has approved for nonprescription sales with a partial OTC switch of azelastine hydrochloride nasal spray, 0.15%.

The FDA’s Center for Drug Evaluation and Research on 17 June announced approval of an application Bayer Healthcare LLC submitted for a nasal antihistamine branded Astepro Allergy and indicated at once- or twice-daily dosing for seasonal allergic rhinitis in adults and

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Rx-to-OTC Switch

Over The Counter: Everything You Wanted To Know About Real World Evidence, With IQVIA’s Volker Spitzer

 
• By David Ridley

HBW Insight finds out all about real world evidence and its potential for the OTC industry by chatting with IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer.

Trump Order To Improve Making More Drugs Available OTC Puts Wind Behind Petros’ ACNU Sails

 
• By Malcolm Spicer

Petros will incorporate into its platform an analytics firm’s automated document capture and authentication system leveraging its global ID library to verify identity and eligibility of consumers accessing the self-selection process for an ACNU switch.

Melatonin And Buccal Acyclovir On German Switch Committee Agenda

 
• By David Ridley

An application for melatonin as an OTC medicine is on the agenda for the next German switch committee meeting, despite the hormone being widely available in food supplements. Acyclovir as a buccal tablet and second-generation antihistamine rupatadine are also up for discussion.

Access To Discounted Naloxone In California Expanded To All Consumers With Potential Need

 
• By Adam Zamecnik

After the product’s initial launch in May 2024, California’s government has now expanded the availability of its CalRx-branded generic OTC Narcan to all of its citizens.

More from Health