Washington Drug Letter

The FTC has asked the Supreme Court to take up and overturn an 11th Circuit Court’s decision that upheld the legality of reverse patent settlements between branded drug makers and generic competitors.

U.S. lawmakers want the FDA to explain who regulates the 28,000 compounding pharmacies operating in the country and how the agency can better control them.

The FTC is challenging a GlaxoSmithKline (GSK)-Teva patent settlement deal, filing an amicus brief that argues authorized generic agreements fall under the category of pay-for-delay deals and are anticompetitive.

Sponsors of clinical studies for antimicrobial drugs to treat acute bacterial sinusitis (ABS) should use superiority trials and demonstrate that the candidate affects the clinical course of the disease, according to finalized FDA guidance on the topic.

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.

The Supreme Court has left intact existing precedents that allow OTC-drug makers to be sued for failing to place warnings on their products that are more robust than the OTC monograph requires.

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

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.

The FDA reclassified its clinical hold on Repros Therapeutics’ Proellex and will now allow the company to conduct a Phase II trial of low-dose Proellex as a treatment for endometriosis.