Washington Drug Letter

The FDA is projecting a sluggish start for its new biosimilars approval pathway.

The GOP-led House easily passed a continuing resolution supported by Democrats and President Barack Obama to keep the FDA and federal government open through March 27.

Drugmakers can use a new FDA-sponsored website to make faster decisions on what experiments or analyses are needed to check for potential drug interactions.

Despite pressure from senators at a roundtable on the implementation of the Physician Payments Sunshine Act, a representative from the Centers for Medicare & Medicaid Services (CMS) simply said the agency hopes the rule will be released soon and that manufacturers’ data collection will begin in 2013.

Eli Lilly has misbranded its radioactive PET drug Amyvid, approved for reviewing displays of brain scans using a black-and-white scale, by featuring a multi-colored brain image on a webpage advertisement and other promotional materials for the product, according to an FDA untitled letter.

BALTIMORE — CDER’s proposed new Office of Pharmaceutical Quality (OPQ) is needed to promote good manufacturing practice (GMP) standards in the preapproval setting — standardizing GMP assessments throughout a drug’s life cycle.

The FDA has approved Genzyme’s once-daily oral drug Aubagio for relapsing multiple sclerosis (MS), setting it up to compete with Novartis’ Gilenya.

In another blow for the bankrupt KV Pharmaceutical, the U.S. District Court for the District of Columbia has dismissed the company’s lawsuit against the FDA.

The FDA has sent Navidea a complete response letter (CRL) on its Lymphoseek injection, citing concerns over quality control at third-party contract manufacturing facilities.

Following setbacks in recent months for Janssen’s blood-clot drug Xarelto, the company has responded to an FDA complete response letter (CRL) on one sNDA for the drug and has re-submitted a separate sNDA.

Qualitest, a subsidiary of Endo Health Solutions, is recalling one lot of its hydrocodone bitartrate and acetaminophen tablets because some may exceed the weight specification and could be super potent.