OTC Decisions Tracker: Dr Reddys NRT Lozenge Approved, Prilosec OTC And Monistat Packaging Revised

HBW Insight introduces an ongoing feature with information on decisions by FDA on NDAs and ANDA for nonprescription drugs and on sNDAs for label and package changes for approved OTC products. Dr Reddys Laboratories' clearance to launch OTC nicotine replacement therapy lozenges in the US and revisions to Prilosec OTC and Monistat packaging were among FDA's s OTC-related decisions in January.

OTC Regulatory Decisions Tracker US

Editor's note: HBW Insight is launching an ongoing feature to provide information on decisions by the US Food and Drug Administration on new drug applications, including ANDAs, for nonprescription drugs and on supplemental NDAs about label and package changes for approved OTC products.

The FDA regularly publishes lists of its decisions on applications for new products and label changes across the US market...

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

More from Regulation

Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 

The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?

NDA User Fees Increasing 8.6% As FDA Projects More Applications But Fewer Sponsor Meetings

 

The ups – and some downs – of the US FDA’s prescription, biosimilar, and generic user fees for FY 2026 are tabulated by the Pink Sheet.

Self-Testing Kits Need To Be Regulated Like OTCs, UK Researchers Argue

 
• By 

Concerns raised by two recent studies prompt UK researchers to argue for greater regulation with regards to direct-to-consumer test kits.

Urban Wastewater Directive: AESGP Requests Intervention In EFPIA’s Legal Action

 
• By 

AESGP has formally submitted a request to the General Court of the European Union to intervene in the European Federation of Pharmaceutical Industries and Association’s legal action against the revised EU Urban Wastewater Directive.

More from Policy & Regulation

Senate HELP Committee Adds Sunscreen Regulation Overhaul To OMUFA Reauthorization

 
• By 

OMUFA reauthorization bill including amendment with sunscreen regulation provisions passed by Senate committee, which also approved other provisions not included in House OMUFA bill.

Urban Wastewater Directive: AESGP Requests Intervention In EFPIA’s Legal Action

 
• By 

AESGP has formally submitted a request to the General Court of the European Union to intervene in the European Federation of Pharmaceutical Industries and Association’s legal action against the revised EU Urban Wastewater Directive.

Sunscreen Regulation Reforms Still Could Hitch Ride On Senate OMUFA Reauthorization Bill

As stakeholders and lawmakers pin their hopes on OMUFA reauthorization as a vehicle for enacting sunscreen regulatory changes, Senate version of the bill could be the ticket after a sunscreen-specific amendment withdrawn in the House.