FDAnews Drug Daily Bulletin

Merck KGaA has withdrawn its EU marketing application for a lung cancer indication for its cancer drug Erbitux after regulatory authorities requested more clinical data.

Amid lingering quality issues at a number of its manufacturing plants, Hospira reported some success in its discussions with the FDA but notes there are more trouble spots than the company previously thought.

In another blow for the bankrupt KV Pharmaceutical, the U.S. District Court for the District of Columbia has dismissed the company’s lawsuit against the FDA.

Lannett Company recently announced that the FDA granted approval to the company’s ANDA for its generic version of Watson Pharmaceuticals’ Fioricet (butalbital, acetaminophen and caffeine) tablets.

A tamoxifen-like drug slowed progression of advanced postmenopausal breast cancer previously treated with a nonsteroidal aromatase inhibitor, according to results of a small Japanese trial.

Blue Cross Blue Shield of Louisiana and other third-party payors struck back at Pfizer in their bid to return their case to multidistrict litigation over alleged off-label marketing of epilepsy drug Neurontin (gabapentin), telling the 1st Circuit they had enough evidence to prove their claims of direct injury.

JHP Pharmaceuticals, a provider of global contract manufacturing services for sterile products, has entered into an agreement with an undisclosed pharmaceutical company to produce supplies of a lyophilized biologic for international, late-phase clinical trials.

Johnson & Johnson’s top executive should be forced to testify about claims that the company illegally marketed the antipsychotic drug Risperdal, which allegedly caused boys to grow breasts, lawyers for a teenager suing the drugmaker said in a court filing.

A federal judge has granted class-action status to former Wyeth shareholders who accused the company, now part of Pfizer, of misleading them about risks associated with the antidepressant Pristiq.