Generic Line

Generic-drug makers won’t have long to wait after Congress passes a user fee bill to learn the various fee levels in the Generic Drug User Fee Act (GDUFA).

An FDA task force is “marching through” development of a project management plan to execute the logistics to support a generic drug user fee program, CDER Director Janet Woodcock told Generic Line in an exclusive interview.

Remediation efforts to right manufacturing woes at Hospira’s Rocky Mount, N.C., facility and other plants are expected to cost between $300 million and $375 million through 2013, but enough progress has been made at Rocky Mount to presume a return to production within weeks, Hospira CEO Michael Ball says.

After months of searching for leadership, GPhA is revamping its upper management with several key hires.

Hospira has begun enrolling patients in a Phase III trial for a U.S. biosimilar of Amgen’s Epogen with results expected next year.

Hearing CEO Paul Bisaro talk about the future of Watson Pharmaceuticals, you might not realize his company is the third largest generic-drug maker in the U.S.

Dr. Reddy’s Laboratories’ failure to prominently display a boxed warning on its website for injectable anticoagulant fondaparinux sodium has landed the company an untitled letter.

The FDA will contract with an independent firm to study workload volume and full costs associated with reviewing biosimilars applications under proposed statutory language for a user fee program.

A federal judge has dismissed a failure-to-warn lawsuit against Mylan, saying the generic-drug maker was preempted from making safety label changes even though its generic was the reference listed drug (RLD).

The Medicare Payment Advisory Commission (MedPAC) has voted to recommend changing copays for low-income Medicare enrollees to encourage generic-drug substitution.

The FDA is encouraging generic-drug makers to use quality by design (QbD) for modified-release products by publishing an example of the development, design and manufacturing of a fictitious modified-release drug using QbD principles.

ANDA sponsors are generally not required to include a sterility assurance quality overall summary (SA-QOS) in sterile product applications, the FDA’s Office of Generic Drugs says.