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The AARP has filed an amicus brief supporting generic drugmaker Teva Pharmaceuticals’ bid to get a federal district court to hear its patent challenge against Pfizer’s lucrative antidepressant Zoloft (sertraline HCl).
The brand pharmaceutical lobby has succeeded in persuading lawmakers in almost half the states to amend Medicaid laws to exempt expensive therapeutic drug classes from substitution rules requiring doctors to prescribe lower-priced alternatives, according to one generic drug executive.
The FDA has determined that the active ingredient in a depression drug marketed before 1962 is effective, rather than “probably effective,” and the agency will use the brand product as a reference-listed drug to approve generic equivalents.
Generic firms Andrx and Teva Pharmaceutical together have launched generic versions of Ortho-McNeil’s oral contraceptive Ortho Tri-Cyclen and Ortho Cyclen-28.
Pharmaceutical Resources (PRX), the parent company of generic drugmaker Par Phramaceutical, yesterday said it would acquire generic firm Kali Laboratories for $135 million – a move that more than doubles PRX’s research and development capabilities.
King Pharmaceuticals has blasted a recent FDA decision allowing generic firms to market versions of King’s muscle relaxant Skelaxin (metaxalone) without labeling that says taking the drug with food increases its bioavailability.
The FTC is urging a federal appeals court to reverse a lower court’s dismissal of generic firm Teva Pharmaceutical’s filing challenging the validity of Pfizer’s patent for the antidepressant Zoloft (sertraline HCl) in a case that could clarify the controversial declaratory judgment provision of last year’s drug patent law.
A U.S. senator, alarmed by the growing momentum at the FDA toward developing an approval process for generic biologics, has urged the agency to address the legal and regulatory foundations before releasing a scientific guidance for producing the complex products.
The Bush administration is proposing new international standards for fixed-dose combination AIDS drugs that could effectively bar generic drugmakers from participating in U.S. funded programs, some U.S. lawmakers and activists groups are charging.
Andrx’s plans to market a version of McNeil Consumer & Specialty Pharmaceuticals’ attention deficit/hyperactivity disorder (ADHD) drug Concerta could face new hurdles if the FDA accepts McNeil’s argument that additional studies are needed to establish bioequivalency.