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The decision came after a court ruled the Norvasc patent to be invalid. Pfizer said it would make the generic amlodipine besylate product immediately through the company’s Greenstone

The company said it anticipates this decision based on feedback provided subsequent to a meeting with the agency this week. Genta can request a re-examination of the initial

The decision came after the company’s investigation of a previously reported precipitation issue. As a result, Hana has chosen to withdraw a new drug application previously submitted to

The FDA did not raise any concerns about the safety of Cimzia or any issues concerning chemistry, manufacturing and controls but asked for an extra study because of

The approved indication is specifically for the short term treatment of impetigo and infected small lacerations, abrasions or sutured wounds. The active substance of Altargo is retapamulin, a

Merck will develop and commercialize Cubicin through its wholly-owned subsidiary, Banyu Pharmaceutical. In exchange for development and commercialization rights in Japan, Merck will pay Cubist $6 million cash

Results showed that cetrorelix, the company’s lead luteinizing hormone-releasing hormone (LHRH) antagonist, was safe and well tolerated at all dosage regimens. Furthermore, Japanese patients responded to cetrorelix with

The SPARC trial is evaluating satraplatin plus prednisone versus placebo plus prednisone in 950 patients with hormone-refractory prostate cancer who have failed prior chemotherapy. “If approved, satraplatin will

This open-label study is designed to access the occupancy of the monoamine oxidase B enzyme (MAO-B) in brain after administration of single oral doses of EVT 302 by