Generic Line

A federal appeals court has poked a hole in generic-drug makers’ preemption protection, ruling that companies can simply stop producing a drug if it is unsafe and the warning label doesn’t reflect all concerns.

Separate congressional committees approved its versions of an omnibus FDA user fee bill making more likely House and Senate floor votes could happen as early as this month.

Amid ongoing efforts to address a previous FDA warning, Impax Laboratories has been hit with a fresh Form 483 after a general inspection unearthed additional quality issues at the company’s Hayward, Calif., facility, further complicating a growing ANDA backlog, the drugmaker says.

Ongoing remediation at Hospira’s Rocky Mount, N.C., plant is on track with the aid of new hires and consultants, the company says.

Senate appropriators overwhelmingly approved a fiscal 2013 spending bill that provides $2.5 billion for the FDA but leaves no new money for biosimilars reviews needed for the agency to collect user fees.

Mylan can launch its generic version of Teva Pharmaceutical’s sleep drug Nuvigil in June 2016 under a settlement agreement between the two companies announced April 30.

Some generic-drug makers who used the discredited contract research organization (CRO) Cetero Research will need to reanalyze or repeat studies, while others will need to conduct an independent third-party data audit, the FDA told drugmakers.

Watson Pharmaceutical’s purchase of Actavis firmly positions it as one of the top generic-drug makers in the world, giving it access to Asian and European markets it didn’t have before.

The FDA has seen a dramatic uptick in early shortage notifications from drugmakers and the number of drug shortages cut in half in the six months since President Barack Obama ordered the agency to request more action from industry.

The U.S. District Court for the District of Columbia has denied ViroPharma’s motion for a temporary injunction to require the FDA to withdraw its approval of three generics of the gastrointestinal antibiotic Vancocin.

The FDA plans to grant expedited reviews for ANDA supplements if they are related to a nationwide drug shortage or meet other criteria, according to a manual of policies and procedures update.

Sandoz now sells all versions of Sanofi’s blockbuster blood-thinner Lovenox, following the launch of 3-mL vials.

Nine brand drugmakers have sought patent term extensions recently, and the FDA has now forwarded relevant product review information to the PTO to help with its decisions.

Since taking the helm as CEO of GPhA last September, Ralph Neas was thrown into the fire, immediately facing a drug shortage crisis, generic user fee program negotiations and FDA development of a biosimilars review pathway and user fee program (Generic Line, Sept. 14, 2011).