Regulatory and Washington

PITTSBURGH — The Food and Drug Administration has approved a generic drug made by Mylan for treating pulmonary arterial hypertension, the drug maker said Tuesday.

Mylan announced the FDA approval of sildenafil citrate tablets in the 20-mg strength, a generic version of Pfizer's Revatio. The drug is used to treat adults with PAH to improve exercise ability and delay clinical worsening of the condition.

Revatio had sales of about $339 million during the 12-month period ended in September, according to IMS Health.

NEW YORK — The American Medical Association has come out in favor of legislation to stop deals between branded and generic drug makers that critics blame for delaying entry of generics into the market, according to published reports.

Forbes reported that the AMA would support federal legislation to ban so-called "pay-for-delay" settlements. The AMA joins the Federal Trade Commission, which has strongly criticized the settlements

ALEXANDRIA, Va. — As many as 85.5% of independent community pharmacies offer patients traditional compounding services, and while it accounts for a small portion of their business, the health-enhancing effect for patients can be dramatic, according to a new survey released Tuesday by the National Community Pharmacists Association.

SAN DIEGO — Health warning labels on cigarette packages that use pictures to show the health consequences of smoking are effective in reaching adult smokers, according to the results of a new study published in the December issue of the American Journal of Preventive Medicine. 

PITTSBURGH — Nearly 160 students, faculty and staff from Duquesne University’s Mylan School of Pharmacy recently visited Capitol Hill to promote the role that pharmacists play in providing medication therapy management services, the university announced Tuesday.

Student pharmacists from the School of Pharmacy’s class of 2015 met with members from 37 U.S. House and Senate offices on Oct. 22 to demonstrate how pharmacist-provided medication therapy management services can improve patient healthcare outcomes and reduce healthcare costs.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic drug for pulmonary arterial hypertension made by Watson Pharmaceuticals, the drug maker said Monday.

Watson said the FDA approved its sildenafil tablets in the 20 mg strength through a subsidiary. Watson said it would launch the drug "in the near future."

The drug is a generic version of Pfizer's Revatio tablets, which had sales of about $339 million during the 12-month period ended in September, according to IMS Health.

CINCINNATI — Procter & Gamble and Teva Pharmaceutical on Monday gained European Union approval for a joint venture on the sale of nonprescription medicines to be called PGT Healthcare, according to published reports. 

According to the reports, the joint venture didn't raise competition concerns. P&G will have a 51% stake in the venture. 

TITUSVILLE, N.J. — The Food and Drug Administration has approved a new strength of a drug for HIV made by Johnson & Johnson, the drug maker said.

J&J subsidiary Janssen Therapeutics announced the approval of an 800-mg formulation of Prezista (darunavir) as a once-daily treatment for HIV. The drug is designed to be taken with food at the same time as ritonavir and in combination with other HIV drugs.