J&J Ultracet Approval Decision Expected By December, Label Talks Underway
Johnson & Johnson expects FDA will make an approval decision on its analgesic Ultracet within two to three months, the company told analysts July 17.
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J&J hopes to receive approval for Ultracet for use in acute pain during May.
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials