Regulatory and Washington

NEW YORK — Earlier this week the National Advertising Division recommended that Bausch + Lomb modify or discontinue certain claims made in an advertorial context that refer to Alcon Laboratories' Opti-Free RepleniSH contact lens solution.

MUMBAI, India — The Food and Drug Administration has approved a contraceptive therapy made by Lupin Pharmaceuticals, the Indian drug maker said Friday.

Lupin announced the approval of Daysee (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets) in the 0.15-mg/0.03-mg and 0.01-mg strengths.

The drug is a generic version of Teva's Seasonique. Various versions of the drug had sales of $161 million in 2012, according to IMS Health.

NORTHRIDGE, Calif. — Pharmavite on Wednesday announced receipt of the brand's official gluten-free certification across its SoyJoy line from the Gluten-Free Certification Organization. 

With this certification, SoyJoy's packaging will feature the official "GF" logo starting this summer. The logo symbolizes standards that the GFCO calls all of its certified brands and restaurants to uphold, specifically the requirement that there be less that 10 ppm of gluten in all raw and finished goods, as well as a required audit of all facilities used in manufacturing

NEW YORK — The government of Canada's Alberta province will pay pharmacists C$1 for each prescription filled as part of a one-year transition program for which it will spend $24 million, according to published reports.

SPARTANBURG, S.C. — QS/1 has released Medicare Part B compliance documentation, which it said would be the first of its type on the market to help pharmacies that want to serve Part B customers while remaining compliant, the company said.

QS/1 said its Medicare Part B Compliance Documentation software system was the first of its kind, allowing pharmacies using NRx or PrimeCare Pharmacy Management Systems to serve Medicare Part B customer needs while keeping necessary documents in the event of an audit.

WASHINGTON — Three Democratic lawmakers on Wednesday released a report that found inconsistencies in the labeling and classification of energy drinks, extensive marketing to adolescents and young adults through social media and events, and high caffeine levels that exceed what is considered safe in soda by the Food and Drug Administration. The report was compiled using responses from 14 energy drink companies received by Rep. Ed Markey, D-Mass., and Sens. Richard Durbin, D-Ill., and Richard Blumenthal, D-Conn., from their investigation into the industry.

WASHINGTON — President Barack Obama has proposed increasing federal taxes on cigarettes, drawing criticism from tobacco companies and praise from anti-smoking groups.

As part of his proposed budget, Obama proposed raising the tax on cigarettes by 94 cents per pack, with similar increases on other tobacco products. The current tax is $1.01 per pack.

WASHINGTON — Legislation designed to limit the use of biosimilars has met defeat in Maryland.