FDA approves Genentech’s new rheumatoid arthritis treatment
SOUTH SAN FRANCISCO, Calif. The Food and Drug Administration has approved a Genentech drug for treating rheumatoid arthritis, the Roche subsidiary announced Friday.
The FDA approved Actemra (tocilizumab) for treating moderately to severely active rheumatoid arthritis in adults who have not responded adequately to tumor necrosis factor therapies. The drug is designed to be used alone or with disease modifying anti-rheumatic drugs such as methotrexate.
“The FDA approval of Actemra marks a major step forward in the treatment of RA, providing a new option for patients with this very serious disease,” Roche and Genentech EVP global development and chief medical officer Hal Barron stated. “We are optimistic that working with the agency, we will be able to generate the additional data required to support approval in earlier lines of RA therapy and are committed to comprehensively characterizing both the clinical benefit and the safety of Actemra in earlier lines of therapy through our large pharmacovigilance program, including the risk management program, and ongoing clinical and post-marketing studies globally.”
Walgreens offering free review sessions to Medicare Part D beneficiaries
DEERFIELD, Ill. Walgreens now is offering free review sessions to Medicare Part D beneficiaries at all of its more than 7,100 pharmacies throughout the country.
Following the open enrollment period for Medicare Part D insurance plans, Walgreens is assisting those beneficiaries who’ve made changes to their prescription drug coverage. Review sessions with Walgreens pharmacists are available daily by appointment through Jan. 31, and are designed to help patients maximize their plan benefits.
Review sessions include:
- A review of beneficiary’s current medications, tiers within their selected plan, co-pays and cost-savings opportunities
- Discussion of available health and wellness services including pneumonia and shingles vaccinations and 90-day prescription benefits
- Checks for potential drug interactions
Watson files FDA application for generic LoSeasonique
MORRISTOWN, N.J. Watson Labs, a subsidiary of specialty pharmaceutical company Watson Pharmaceuticals, has filed an abbreviated new drug application to the Food and Drug Administration for an oral contraceptive.
Watson is seeking approval to market its levonorgestrel and ethinyl estradiol (0.10-mg/0.02-mg) oral contraceptive product prior to the expiration of U.S. Patent No. 7,615,545, which is owned by Duramed Pharmaceuticals, a subsidiary of Teva. Watson’s levonorgestrel and ethinyl estradiol product is a generic version of Teva’s LoSeasonique, which is indicated for the prevention of pregnancy.
On Nov. 23, 2009, pursuant to the Hatch-Waxman Act, Watson notified Duramed that its ANDA requesting approval from the FDA for a generic version of LoSeasonique contained a paragraph IV certification asserting that the LoSeasonique patent is invalid, unenforceable and/or not infringed. Teva Women’s Health filed suit against Watson on Jan. 6, 2010 in the U.S. District Court for the District of New Jersey seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 7,615,545. Based on available information, Watson believes it may be entitled to 180 days of generic market exclusivity or shared exclusivity should its product receive approval.