Regulatory and Washington

SILVER SPRING, Md. — Two Dallas-based compounding pharmacies announced a recall of sterile drug products made at their facilities due to production conditions that could lead to contamination.

The Food and Drug Administration said Tuesday that ApotheCure had recalled all sterile drug products made at its pharmacy, while NuVision Pharmacy had recalled sterile freeze-dried or lyophilized drug products made at its facility. Both recalls were described as voluntary.

NEW YORK — Purdue Pharma's patent for OxyContin expired Tuesday, opening up the opioid painkiller to generic competition, but authorities have raised concerns about what they call the potential for generic versions to be abused.

DUBLIN — The Food and Drug Administration has approved a new strength of an antibiotic made by Warner Chilcott, the drug maker said.

Warner Chilcott announced the approval of the 200-mg strength of Doryx (doxycycline hyalite) delayed-release tablets, which the company plans to release in July 2013.

Doryx delayed-release tablets are already available in the 75-mg, 100-mg and 150-mg strengths.

ALEXANDRIA, Va. — The governor of North Dakota has signed into law a bill that would require pharmacy benefit managers to inform pharmacies about how reimbursement for generic prescription drugs is calculated under maximum allowable cost benchmarks and provide a more detailed appeals process to pharmacies to contest the MAC reimbursement caps that PBMs set up.

The bill, H.B. 1363, received unanimous support in both houses of the state's legislature, and Gov. Jack Dalrymple signed it into law Monday.

RESEARCH TRIANGLE PARK, N.C. — Vitamin D significantly reduces women's risks of developing uterine fibroids, according to a new study.

WASHINGTON — Generic makers heralded the fiscal year 2014 budget proposed last week by the Obama administration for its embrace of generic drugs, but were critical of its provisions on patent settlements and rebates.

SILVER SPRING, Md. — An inspection of more than two-dozen compounding pharmacies by Food and Drug Administration officials has found widespread problems with sanitation and sterilization practices, FDA commissioner Margaret Hamburg wrote in a blog post on the agency's website Thursday.

SAN DIEGO — Celgene Corp. chairman and CEO Robert Hugin has been elected as chairman of a pharmaceutical industry trade group.

The Pharmaceutical Research and Manufacturers of America announced the election of Hugin, as well as Pfizer president and CEO Ian Read as chairman-elect of the PhRMA board of directors and Merck chairman, president and CEO as board treasurer.

Hugin succeeds Eli Lilly president, chairman and CEO John Lechleiter as chairman, PhRMA said.