Regulatory and Washington

NEW YORK — The Food and Drug Administration has approved a medication designed to treat acute and chronic moderate to severe pain, where the use of an opioid analgesic is suitable.

Pfizer and Acura Pharmaceuticals said that their drug Oxecta (oxycodone HCl, USP tablets) is the first tamper-resistant medication designed to deter abuse and misuse with Aversion technology, which is being licensed by Pfizer from Acura.

GALASHIELS, Scotland, and BEDMINSTER, N.J. — ProStrakan has received approval from the Food and Drug Administration to market an ointment designed to treat moderate to severe pain associated with chronic anal fissures.

The drug maker, which is a subsidiary of Kyowa Hakko Kirin, said that it received regulatory approval for Rectiv (nitroglycerin) ointment 0.4%. Rectiv currently is the only FDA-approved prescription product for patients with this condition. ProStrakan expects Rectiv to be available in the United States in first quarter 2012.

SILVER SPRING, Md. — The Food and Drug Administration Tuesday approved the first generic versions of an antibiotic designed to treat certain infections in people ages 18 years and older.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores once again is offering retailers and suppliers the opportunity to meet and work together to bring new, innovative products to market.

NACDS' 2011 Marketplace Conference will unite industry leaders from drug, food, mass, dollar and specialty retail at the Boston Convention & Exhibition Center from June 25 to 28.

WASHINGTON — The Department of Health and Human Services on Tuesday morning unveiled the nine graphic health warnings mandated by the Food and Drug Administration to appear on every pack of cigarettes sold in the United States and in every cigarette advertisement.

The warnings represent the most significant changes to cigarette labels in more than 25 years and will affect everything from packaging to advertisements. The warnings are required to be placed on all cigarette packs, cartons and ads no later than September 2012.

PARSIPPANY, N.J. — Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

The company filed an abbreviated new drug application to market dutasteride capsules in the 0.5-mg strength. The drug is a generic version of Avodart, which is made by GlaxoSmithKline.

TARRYTOWN, N.Y. — A panel of Food and Drug Administration experts has recommended approval of an investigational biotech drug made by Regeneron Pharmaceuticals for eye diseases.

Regeneron said Friday that the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee unanimously recommended approval of Eylea (aflibercept) ophthalmic solution for the treatment of a form of age-related macular degeneration, also known as wet AMD. The disease causes abnormal growth of new blood vessels in the eye.

ABBOTT PARK, Ill. — The Food and Drug Administration has approved a new formulation of an injectable drug made by Abbott for prostate cancer.

Abbott announced Monday the approval of a 45-mg, six-month formulation of Lupron Depot (leuprolide acetate) for advanced prostate cancer. Previous formulations have allowed patients to receive the drug every month or every three or four months.