Content about Food and Drug Administration

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

Warner Chilcott announced the approval of Minastrin 24 FE (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) for prevention of pregnancy.

The drug maker said an unnamed third-party company would manufacture the drug, but it did not expect to launch it this year.

BASEL, Switzerland — The Food and Drug Administration has approved a drug made by Alcon, the drug maker said.

The Food and Drug Administration over the past year has been exploring ways to further increase the value of the over-the-counter medicine space through the utilization of technology to support new Rx-to-OTC switches. In-store diagnostic tools that help improve compliance, contribute to a HIPPA-compliant health record and increase interception opportunities between pharmacists and patients, like those fielded by PharmaSmart, are the kind of in-store support tools that the FDA is reviewing.

President Barack Obama sent his $3.8 trillion budget proposal to Congress on April 10, and the plan includes a number of provisions designed to cut spending on health care and promote health and wellness.

Overall, the budget is something of a mixed bag for the healthcare industry. While it would provide incentives for expanding the use of generic drugs, for example, it would also cut spending on Medicaid that have drawn opposition from pharmacy retailers, and even generic drug makers disagree with some of its provisions for that industry.

LONDON — A Food and Drug Administration panel has recommended that the agency approve an experimental drug for chronic obstructive pulmonary disease made by GlaxoSmithKline and Theravance, the two companies said.

The FDA Pulmonary-Allergy Drugs Advisory Committee voted 9-4 to recommend Breo Ellipta as a long-term maintenance treatment for airflow obstruction in patients with COPD and for reduction of COPD exacerbations in patients with a history of them. The drug is a once-daily inhaler that combines fluticasone furoate and vilanterol.

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.

SILVER SPRING, Md. — The Food and Drug Administration will not approve generic versions of Purdue Pharma's painkiller OxyContin based on earlier versions of the drug that did not include features to thwart abuse, the agency said Tuesday.

The FDA announced that it approved updated labeling for reformulated OxyContin (oxycodone) extended-release tablets indicating that it has physical and chemical properties designed to deter drug abusers from crushing or dissolving the pills in order to inject or snort them.

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.

SAN DIEGO — The Food and Drug Administration is granting an expedited application process to a company that has developed a treatment for a condition related to Parkinson's disease, meaning that it can cancel a planned late-stage clinical trial, the company said.

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.

ROSEMONT, Pa. — The Food and Drug Administration has approved a drug for treating nausea and vomiting during pregnancy.

Drug maker Duchesnay USA said the FDA approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets in the 10 mg/10 mg strength for NVP, more commonly known as morning sickness, in women who don't respond to conservative treatment. NVP is estimated to affect 70-85% of pregnant women, and symptoms range from nausea to severe vomiting and retching that can last throughout the day.

PARSIPPANY, N.J. — Actavis will market and distribute an authorized generic version of a genital herpes ointment made by Valeant Pharmaceuticals International, the companies said Friday.

The agreement centers around Zovirax, known generically as acyclovir, in the 5% strength. The Food and Drug Administration approved the generic version, made by Mylan, on Wednesday. Financial terms of the deal were not disclosed.