Generic Line

The timely passage of a generic drug user fee bill is uncertain after the Senate failed to close debate on the bill late Monday, agreeing to re-open debate Tuesday.

The FTC may not issue the advisory opinion GPhA is waiting for before launching its third-party drug shortage program, possibly derailing the initiative.

The generic-drug industry says it could not support an omnibus FDA user fee bill if a provision to change the first-filer exclusivity is added to the bill.

Drugmakers looking to branch into biosimilars shouldn’t raise their hopes for quick FDA guidance on achieving interchangeability status.

Apotex and a host of other generic-drug companies can finally launch copycat versions of blockbuster blood-thinner Plavix as Sanofi and Bristol-Myers Squibb’s (BMS) ’265 patent expired May 17.

Wall Street analysts predict Actavis’ ANDA on attention-deficit hyperactivity disorder (ADHD) drug Intuniv won’t infringe Shire’s patents, and the generic-drug maker could launch as soon as October if it wins approval.

Three Senators are urging the FDA to end generic labeling preemption and allow generic-drug makers to make warning label changes even if it will no longer mirror the brand-drug label.

Novartis is suing generic-drug makers Lupin and Torrent Pharmaceuticals after the two filed ANDAs referencing its hypertensive drug Exforge HCT.

Hospira is recalling one lot of hydromorphone hydrochloride injection after two reports of overfills in the syringe-based drug delivery system.

Actavis is launching generic versions of GlaxoSmithKline’s (GSK) Parkinson’s disease drug Requip XL and believes they are the first in the U.S.