Regulatory and Washington

WAYNE, N.J. — The Food and Drug Administration has approved a drug that the manufacturer called the first oral contraceptive that also treats heavy menstrual bleeding.

Bayer HealthCare Pharmaceuticals announced Wednesday the approval of Natazia (estradiol valerate and estradiol valerate and dienogest) tablets for heavy menstrual bleeding not caused by any conditions of the uterus. The drug was originally approved as an oral contraceptive in May 2010.

ALEXANDRIA, Va. — Legislation designed to reform the pharmacy audit process has been approved in Utah and will be sent to the state governor to sign.

In a 73-1 vote, H.B. 76, known as the Pharmacy Audit Integrity and Recovery Act, "requires health benefit plans, the Public Employees' Benefits and Insurance Program and pharmacy benefit managers to implement certain pharmacy audit procedures when auditing pharmacy claims," according to the legislation document. Key provisions included:

CHADDS FORD, Pa. — Endo Pharmaceuticals is hoping the Food and Drug Administration will back tougher regulatory approval requirements for generic versions of one of its drugs.

SILVER SPRINGS, Md. — The Food and Drug Administration has approved the first generic version of an antidepressant made by Forest Labs, the agency said Wednesday.

The FDA announced the approval of a generic version of Lexapro (escitalopram) made by Teva Pharmaceutical Industries in the 5-mg, 10-mg and 20-mg strengths. The drug is used to treat depression and generalized anxiety disorder in adults.

NEW YORK — Forest Labs has filed suit against Glenmark Generics and several other companies, alleging that they infringed on its patent for a drug to treat hypertension by seeking regulatory approval for generic versions.

Forest and Johnson & Johnson subsidiary Janssen Pharmaceutica NV have sued Glenmark, Hetero USA, Torrent Pharmaceuticals and Watson Labs in response to their filing regulatory approval applications with the Food and Drug Administration for generic versions of Bystolic (nebivolol).

WASHINGTON — The National Association of Chain Drug Stores is heading to Capitol Hill next week for its RxImpact Day event, during which it will press its case against the proposed ESI-Medco merger.

“No issues are higher on NACDS’ list of priorities than urging members of Congress to express to the Federal Trade Commission their concerns and opposition to the proposed Express Scripts and Medco merger, and advocating for legislation to regulate pharmacy benefit managers,” stated NACDS president and CEO Steve Anderson.

NEW YORK — One-third or more of rogue online pharmacy domains are under one Internet registrar, with two registrars accounting for more than half, according to a new report.

WASHINGTON — West Virginia has become the 19th state to require pharmacists and other retailers to be connected through the National Precursor Log Exchange system with the passage of legislation that requires real-time, stop-sale technology to enable the state's pharmacists to block illegal pseudoephedrine purchases right at the point of sale and provide law enforcement with up-to-the minute criminal data.