Teva Pharmaceuticals USA Inc.
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Latest From Teva Pharmaceuticals USA Inc.
Teva’s ‘Skinny Label’ Dispute Edges Toward Supreme Court With Government’s Backing
US Solicitor General urges the Supreme Court to grant Teva's petition, arguing that the Federal Circuit was wrong in ruling that Teva's carved-out labeling for generic carvedilol induced infringement of GlaxoSmithKine's brand product.
iPLEDGE REMS: US FDA Advisory Cmte. Supports Relaxing Restrictions But Wants More Data
Panel favors elimination of 19-day lockout after missed prescription pickup and continuation of at-home pregnancy tests. Members call for more data from isotretinoin sponsors on why acne patients are not participating in pregnancy registry and on disparities by race and ethnicity.
iPLEDGE REMS: FDA Panel To Consider Changing Pregnancy Testing, Counseling Requirements
Advisory committee to discuss proposed changes to isotretinoin REMS to minimize burden and treatment delays while preventing risk of fetal exposure. Agency recommends against at-home pregnancy tests.
The Same But Different: Biden Budget Proposes Flexibility For Generic Drug-Device Combos, ‘Skinny Labels’
President Biden's fiscal year 2024 budget pushes new legislative changes to get generic drugs to market faster.
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