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Generic firms can develop generic biologics using available raw materials, and the FDA can approve the products as fully substitutable for their brand equivalents under current regulations, according to Barr Pharmaceuticals’ executives, who challenged some commonly held perceptions about the complex molecules.
The FDA is examining various strategies to increase compliance with a law mandating that companies engaged in clinical trials of drugs for serious or life-threatening diseases post notices about study data on a federal website.
The FDA is stepping up its efforts to get pharmaceutical companies to submit more complete applications for new molecular entities (NMEs) — an action the agency believes could expedite the drug approval process.
Beginning with today's issue, your FDAnews publication will be delivered to you in a new, interactive PDF format designed to eliminate the need for scrolling through the document to find a story or to read the continuation of an article.
GlaxoSmithKline (GSK) has filed a citizen petition asking the FDA to delay approving generic versions of its allergy nasal spray Flonase (fluticasone propionate) until the agency issues final guidance on establishing equivalency for inhalers.
The new Medicare drug discount card offers savings of up to 92 percent on commonly used prescription drugs if beneficiaries buy generics instead of brand drugs, a study by the Centers for Medicare & Medicaid Services (CMS) found.
The FDA has approved 15 generic versions of ciprofloxacin, the drug that emerged as the antibiotic of choice during the anthrax attacks on Capitol Hill in 2001.
Andrx has relinquished its 180-day exclusive marketing rights for a 150-mg strength version of GlaxoSmithKline’s (GSK’s) smoking cessation drug Zyban (bupropion HCl), a move that allows generic firms to start marketing the drug.
The FDA should issue regulations that would eliminate a brand company’s ability to license an authorized generic product until the first generic applicant’s 180-day exclusivity period has expired, the Generic Pharmaceutical Association (GPhA) has told the agency.
The FDA will not release its draft guidance detailing the scientific issues on follow-on biologics this summer as originally announced, according to a top agency official who also said the FDA will not approve generic biologics for products that can’t be characterized.