FDA approves Mylan antidepressant after company reaffirms efficacy
PITTSBURGH — The Food and Drug Administration has approved a supplemental regulatory application from Mylan for a generic antidepressant that was subject last year to scrutiny by the agency amid reports of efficacy problems, Mylan said Thursday.
The drug maker announced the approval of its supplemental abbreviated new drug application, or sANDA, for bupropion hydrochloride extended-release tablets in the 300-mg strength. The drug is a generic version of GlaxoSmithKline’s Wellbutrin XL.
Last year, the FDA requested makers of generic versions of Wellbutrin XL to conduct studies to determine whether their versions were equivalent to the branded drug following reports that a company’s generic version had lower efficacy. By law, all generic drugs must be as safe and effective as their branded counterparts.
Bupropion hydrochloride extended-release tablets in the 150-mg and 300-mg strengths had sales of about $503.3 million during the 12-month period that ended in June, according to IMS Health.
EarthTronics introduces new dimmable bulbs with big energy savings
MUSKEGON, Mich. — EarthTronics announced this week PAR20, PAR30 and PAR38 EarthBulb LED floodlights, which offer more than 80% savings compared with standard floodlights, the company stated. EarthTronics dimming technology provides smooth dimming to less than 5% on standard controls. EarthBulb LED PAR lamps are ideal for use in display lighting, track lighting and recessed lighting applications for hospitality, restaurant, long-term care and retail locations.
According to the company, EarthBulb LED PAR20, PAR30 and PAR38 provide 490, 800 and 1200 lumens respectively and replace 50-watt, 75-watt and 120-watt incandescent floodlights. EarthBulb LED PAR lamps are designed with the same form factor as the PAR lamps that they are replacing. EarthBulb LED floodlights make an excellent replacement for standard incandescent bulbs and halogen PAR bulbs.
Each of the EarthBulb LED PAR floodlights offers:
- 3000K white light with high color rendering rating of greater than 80;
- Single chip LED design is ascetically pleasing;
- Medium screw base (E26) for easy installation;
- Wet location rating on both the PAR30 and PAR38;
- 40-degree and 25-degree light beam angles are available;
- Advanced LED cooling system to ensure performance for up to 40,000 hours; and
- Three-year standard Energy Star warranty.
EarthBulb LED lamps are available at retailers nationwide and can be purchased online. For more information about EarthBulb products, visit Earthtronics.com.
Founded in 2007, EarthTronics is a Michigan-based company located in Muskegon. Its products are sold under the EarthBulb brand name and are found in commercial buildings, hotels, restaurants, retail stores and residential homes. All EarthBulb lamps provide more than 75% energy savings. EarthTronics energy-efficient lighting solutions include CFL lamps from 5-watt to 65-watt that replace 25-watt to 300-watt incandescent lamps and LED solutions for decorative and display lighting, downlights and general area lighting.
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Calif. state legislature mulls biosimilar carve-out legislation
SACRAMENTO, Calif. — A bill under consideration by California’s state legislature contains provisions that would place restrictions on pharmacists’ ability to dispense knock-off versions of biotech drugs, drawing opposition from the generic pharmaceutical lobby and the state’s pension fund for government employees.
The provision in the bill, SB 598, would require pharmacists to notify prescribers and patients if they have substituted a biosimilar and also forbid pharmacists from substituting biosimilars if prescribers indicate "Do not substitute" on prescriptions. The bill is one of several sponsored by biotech giants Amgen and Genentech that have appeared in state legislatures.
On Wednesday, the board of the California Public Employees’ Retirement System voted to oppose the provision and oppose passing the bill unless it is removed, drawing praise from the Generic Pharmaceutical Association.
"Passing SB 598 with this provision intact would prevent the state of California from realizing the full cost savings from new, safe and affordable medicines," GPhA president and CEO Ralph Neas said. "As health costs continue to strain the state’s fiscal security and the use of biologic medicines increases, we urge California lawmakers to reject this bill."