Regulatory and Washington

ALEXANDRIA, Va. — The merger agreement between Medco Health Solutions and Express Scripts announced Thursday has drawn objections from retail pharmacy trade groups.

In a joint statement on Thursday, National Community Pharmacists Association EVP and CEO Douglas Hoey and National Association of Chain Drug Stores president and CEO Steve Anderson said Express Scripts’ $29.1 billion acquisition of Medco would “exacerbate [pharmacy benefit managers’] detrimental effect on pharmacy patient care.”

WASHINGTON — The Partnership for a Healthier America, together with First Lady Michelle Obama, on Wednesday afternoon hosted a press conference announcing that leading grocery retailers have committed to bring healthy, affordable food to nearly 10 million people over the next five years in the form of new and expanded stores in areas that desperately need them.

AMITYVILLE, N.Y. — Hi-Tech Pharmacal has introduced levofloxacin oral solution in the 25-mg/mL strength, the drug maker said Tuesday.

The drug will be available in 480-mL, 200-mL and 100-mL sizes in order to allow pharmacists to tailor inventory to store volume. Hi-Tech was granted tentative approval in April.

The drug is a generic version of Johnson & Johnson’s pneumonia treament Levaquin.

GREENSBORO, N.C. — Lorillard has voluntarily recalled certain Newport non-menthol cigarettes.

The recall was initiated after the company discovered that some of the cigarettes manufactured between June 29 and 30 could contain small pieces of plastic. At this point, no plastic has been found in any of the cigarettes, but if burned, the plastic may create respiratory discomfort or irritation, Lorillard said.

WILMINGTON, Del. — A Food and Drug Administration committee of experts has advised against approving a drug for Type 2 diabetes made by AstraZeneca and Bristol-Myers Squibb, the companies said Tuesday.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 9-6 against recommending approval for dapagliflozin, saying that data from a two-year clinical trial program that included about 6,000 people did not support the drug’s approval for use in patients along with changes to diet and exercise.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new influenza vaccine formulation for the 2011-2012 flu season, the agency said Monday.

The FDA said six manufacturers are licensed to produce vaccines. These include GlaxoSmithKline Biologicals, manufacturing Fluarix; CSL Limited, manufacturing Afluria; ID Biomedical, manufacturing FluLaval; MedImmune Vaccines, manufacturing FluMist; Novartis Vaccines and Diagnostics, manufacturing Fluvirin; and Sanofi Pasteur, manufacturing Fluzone.

THOUSAND OAKS, Calif. — Generic drug maker Teva recently admitted that one of its drugs infringes two of Amgen's patents.

The U.S. District Court in Pennsylvania has barred Teva from selling its human G-CSF (human granulocyte colony-stimulating factor) product Neutroval in the United States until Nov. 10, 2013. What's more, the court's injunction extends to Teva's other human G-CSF product, Neugranin. Teva will not sell Neugranin until Nov. 10, 2013, unless it first obtains a final court decision that Amgen's patents are not infringed by Neugranin.

SILVER SPRING, Md. — The Food and Drug Administration will sponsor a chat session via Twitter concerning proposed guidelines for health-related apps, the agency said Tuesday.

The chat session will begin at 3 p.m. on Twitter.com/US_FDA.