Perrigo Company PLC
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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
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.
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ACNU rule published in June, but the firm, which worked with Ibis Reproductive Health on proposal, had time to plumb a draft guidance FDA published in 2018 on novel switches.
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.
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Pharmaceuticals
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Molecular Diversity
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Molecular Diversity
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