Washington Drug Letter

The FDA will likely see its budget reduced by $294 million if across-the-board cuts to federal programs go into effect on Jan. 2, 2013, as currently planned; the cuts are needed to comply with a congressional mandate to reduce the federal deficit.

A string of long-pending pay-for-delay cases against Cephalon are being placed on hold while the Supreme Court decides whether to grant Merck’s request and rule on the validity of reverse patent settlements — a hotly contested issue that has resulted in conflicting decisions throughout the nation’s lower courts.

Bristol-Myers Squibb (BMS) is recalling 10 lots of its cancer drug BiCNU, manufactured by Ben Venue Laboratories, after finding a single overfilled vial during routine testing.

The FDA’s Anti-Infective Drugs Advisory Committee has recommended the FDA approve Novartis’ inhaler-based version of cystic fibrosis (CF) drug Tobi.

Sun Pharmaceutical is recalling one lot of its 30-mg nimodipine after a customer complaint about possible crystallization of the solution inside the capsule.

Medivation and Astellas expect their oral prostate cancer treatment Xtandi will be available mid-September, following an Aug. 31 FDA approval.

DPT Laboratories’ investigations into batch failures at its Lakewood, N.J., plant are inadequate and heighten concern about microbiological contamination of topical drugs, according to an FDA warning letter.

Pfizer and the FDA are warning against off-label use of the company’s Revatio in children up to 17 years old with pulmonary arterial hypertension (PAH).

GlaxoSmithKline (GSK) is suing Apotex, saying the generic maker’s proposed version of enlarged prostate drug Avodart would infringe on a GSK patent and should be prohibited from the U.S. market until the patent expires in late 2015.

The FDA has OKed Pfizer’s Bosulif, a once-daily pill to treat chronic myelogenous leukemia (CML), marking the pharma giant’s third new oncology drug approval in a little more than a year.

The FDA has approved Novartis’ Afinitor to treat a rare brain tumor called subependymal giant cell astrocytoma (SEGA) in children, expanding its indication for the condition.

The FDA continues to approve cancer drugs more quickly than the European Medicines Agency (EMA), clearing them in about half of the time regardless of the drugs’ designation, according to a recent study.

Impax Laboratories can market generic versions of Genzyme’s kidney disease drugs Renvela and Renagel in 2014 under a settlement with the brand drugmaker.