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FDA to debate pediatric APAP dosing during mid-week advisory committee meeting
WASHINGTON — The Food and Drug Administration is convening its Nonprescription Drugs Advisory Committee Tuesday and Wednesday to debate mandating weight-based dosing for pediatric medicines containing acetaminophen on the Drug Facts label, as well as the potential expansion of dosing instructions to incorporate children under the age of 2 years old, according to material posted online by the FDA on Friday.
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Amylin accuses Lilly of anticompetitive activity in diabetes drug development, commercialization
SAN DIEGO — Amylin Pharmaceuticals filed suit against Eli Lilly in federal court Monday concerning an agreement between the latter and German drug maker Boehringer Ingelheim to develop drugs for diabetes.
In a complaint filed in the U.S. District Court for the Southern District of California, Amylin said Lilly engaged in unlawful and anticompetitive activity in its development and commercialization agreement with BI for Tradjenta (linagliptin), an orally administered Type 2 diabetes drug that the Food and Drug Administration recently approved.