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Latest From Perrigo Company PLC

Age-Restriction Labeling, Behind-The-Counter Sales Likely In HRA's US OTC Contraceptive NDA

“I think the issue is whether it is going to have age restricted labeling, which would be a political issue rather than a medical issue,” says 

FDA Politics

OTC Daily Oral Contraceptive Proposal In US Packs Promise Of Access, But Peril Of Single Option

Discussion of whether progestin-only formulation will be approved for OTC sales and succeed in the US nonprescription market perhaps has been overshadowed by expectations of political pressures affecting FDA’s evaluation and decision after HRA submitted its NDA.

Prescription To OTC Switch Drug Approval Standards

US OTC Birth Control NDA Could Debut ‘Additional Conditions for Nonprescription Use’ Labeling

HRA didn't have time to incorporate into its switch NDA instructions stated in proposed ACNU rule published in June, but the firm, which worked with Ibis Reproductive Health on proposal, had time to plumb a draft guidance FDA published in 2018 on novel switches.

Prescription To OTC Switch Drug Approval Standards

Ranitidine Litigation Opens With Settlements, But Still Massive With State And MDL Trials Pending

GSK and Sanofi will continue to defend against all claims alleging ranitidine increased risk of cancer. Four Rx generic firms reach settlements in first case scheduled for trial. Former US OTC Zantac marketers GSK and Sanofi, which markets the Zantac OTC brand in the US, along with former Rx brand marketer Pfizer could pay $1bn to $2bn each in potential settlements, analyst predicts.

Ingredients Legal Issues
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