Drug Industry Daily

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Apotex is taking the FDA to court for failing to grant timely approval of its ANDAs for two Sanofi hypertension treatments, Avapro and Avalide.

Public Citizen is urging the FDA to require boxed warnings on the labels of many top-selling hypertension drugs, including angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs) and Novartis’ aliskiren, to warn against their use in combination.

ANDAs that lack basic quality-by-design (QbD) elements will be categorized as requiring “major” amendments and more extensive FDA consideration, according to a new Manual of Policies and Procedures (MAPP) for reviewers in CDER’s Office of Generic Drugs (OGD).

An international offensive against thousands of online peddlers of counterfeit and illicit drugs has resulted in the seizure of some 3.75 million units with an estimated value of $10.5 million.