Regulatory and Washington

SILVER SPRING, Md. — The Food and Drug Administration has unveiled two regulations, part of the newly enacted Food Safety Modernization Act, that will take effect in July.

PITTSBURGH — A generic drug maker has launched its version of a pain medication made by Endo Pharmaceuticals.

Mylan and its subsidiary Mylan Pharmaceuticals launched oxycodone and aspirin tablets USP in the 4.8355-mg/325-mg strength, based on an agreement with licensing partner Coastal Pharmaceuticals. The drug, designed to treat moderate to severe pain, is a generic version of Percodan.

Oxycodone and aspirin tablets had U.S. sales of approximately $6.5 million for the 12 months ended Dec. 31, 2010, according to IMS Health.

WASHINGTON — The Consumer Healthcare Products Association on Wednesday announced plans to convert liquid pediatric acetaminophen products to just one concentration.

This voluntary change means the current children’s strength of liquid acetaminophen (160 mg/5 mL) will become the only liquid concentration available for all children younger than 12 years, and the current concentrated infant drops no longer will be sold.

PRINCETON, N.J. — The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the generics arm of Swiss drug maker Novartis said Wednesday.

Sandoz announced the approval of Loryna (drospirenone 3 mg and ethinyl estradiol 0.02 mg) tablets, a generic version of Bayer HealthCare Pharmaceuticals’ Yaz.

SILVER SPRING, Md. — The Food and Drug Administration is cracking down on companies that it accuses of selling fake products for sexually transmitted diseases, the agency said.

The FDA said at least 15 products — some sold as dietary supplements — that claim to treat, prevent or cure such STDs as herpes, Chlamydia, genital warts and HIV/AIDS, were being sold online and at some retail stores. Brands include MedaVir, which claims to treat herpes; Gene-Eden, which claims to treat a range of STDs, as well as flu and mononucleosis; and several others.

ALEXANDRIA, Va. — The National Community Pharmacists Association's membership has expanded to include a buying and advertising cooperative that offers rebates and signage to independently owned pharmacies.

Quality Care Pharmacies — a Springville, N.Y.-based company that boasts more than 450 member pharmacies in New York, New Jersey, Pennsylvania, Connecticut and Ohio — has joined NCPA, the association said.

WASHINGTON — With the number of Americans with diabetes set to rise to 50 million by 2025, educating people is one of the most important steps for heading off the epidemic.

ALLEGAN, Mich. — The Food and Drug Administration has approved a generic version of Rogaine made by Perrigo, the drug maker said.

Perrigo announced the FDA approval of over-the-counter minoxidil foam, a generic version of men’s Rogaine foam.

Stiefel Research Australia, part of GlaxoSmithKline, sued Perrigo for patent infringement when the latter submitted its regulatory approval application. Under a settlement between the companies reached in February, Perrigo can launch its generic version of men’s Rogaine foam in March 2012.