The U.S. Food and Drug Administration (FDA) generic drug program has launched a new pilot program to offer meeting opportunities to generic drug applicants who intend to use model-integrated evidence (MIE) approaches to...more
The U.S. Food and Drug Administration (FDA) recently published the draft guidance “Sameness Evaluations in an ANDA – Active Ingredients,” which aims to assist applicants preparing an abbreviated new drug application (ANDA) by...more
Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its October 2020 decision that a labeling...more
8/26/2021
/ Abbreviated New Drug Application (ANDA) ,
CAFC ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Induced Infringement ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a labeling carve-out by a generic drug sponsor did not preclude a finding of...more
10/29/2020
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Carve Out Provisions ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
GlaxoSmithKline ,
Orange Book ,
Patent Infringement ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
Product Labels ,
Teva Pharmaceuticals
FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved Drug Products with Therapeutic Equivalence Evaluations) provides the...more
2/4/2019
/ Abbreviated New Drug Application (ANDA) ,
Comment Period ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Orange Book ,
Patent Applications ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Product Packaging ,
Regulatory Agenda