Regulatory and Washington

WASHINGTON — The Natural Products Association on Thursday launched a grassroots campaign to oppose the Dietary Supplement Labeling Act, recently introduced in Congress by Sen. Richard Durbin, D-Ill., and is urging its more than 1,900 members to ask their legislators to oppose the legislation by sending them a letter at NPAinfo.org/Durbin.

PARSIPPANY, N.J. — Watson Pharmaceuticals has filed with the Food and Drug Administration for regulatory approval for a drug to treat attention deficit hyperactivity disorder, the company said Thursday.

Watson said it submitted its application for lisdexamfetamine dimesylate capsules, a generic version of Shire’s Vyvanse.

HYDERABAD, India — Dr. Reddy’s Labs has launched a generic drug for treating high blood pressure, the company said Thursday.

Dr. Reddy’s announced the launch of amlodipine besylate and benazepril hydrochloride capsules in the 5-mg/40-mg and 10-mg/40-mg strengths.

The drug is a generic version of Novartis’ Lotrel, which had sales of $290 million during the 12-month period ended in March, according to IMS Health.

BALTIMORE — The Food and Drug Administration has approved an additional strength of a generic drug made by Lupin Pharmaceuticals for high blood pressure, Lupin said Wednesday.

Lupin announced the approval of amlodipine besylate and benazepril hydrochloride capsules in the 5-mg/40-mg and 10-mg/40-mg strengths. The company already markets the drug in the 2.5-mg/10-mg, 5-mg/10-mg, 5-mg/20-mg and 10-mg/20-mg strengths.

ALEXANDRIA, Va. ­— The National Association of Chain Drug Stores has submitted comments to the Centers for Medicare and Medicaid Services regarding a proposed rule that would help to determine Medicaid beneficiary access to pharmacies and other healthcare providers.

NACDS urged CMS to ensure access to healthcare services for Medicaid beneficiaries that are comparable with the access that the general population has in a given geographic area, a requirement of the federal standard.

WASHINGTON — The National Retail Federation said last week that it was disappointed in the final debit card swipe-fee regulations set by the Federal Reserve.

Under the new rule, the current debit card swipe-fee rate of 1% to 2% of each transaction will be replaced with a flat fee of not more than 21 cents per transaction for the nation’s largest banks — substantially higher than the flat fee of up to 12 cents the Federal Reserve originally proposed in December 2010.

DUBLIN — Shire has filed patent infringement suits against two generic drug makers relating to its attention deficit hyperactivity disorder treatment.

Shire said it has filed lawsuits in the U.S. District Court for the District of New Jersey against Amneal Pharmaceuticals and Sandoz. Amneal and Sandoz recently filed abbreviated new drug applications with the Food and Drug Administration to market generic Vyvanse (lisdexamfetamine), an ADHD drug.

SCHAUMBURG, Ill. — APP Pharmaceuticals has received regulatory approval for the treatment of a complication related to hypothyroidism.

APP said that its levothyroxine sodium for injection will be marketed in single-dose 100-mcg, 200-mcg and 500-mcg vials. The drug is designed to treat myxedema coma, a life-threatening complication of hypothyroidism.