Generic Launched for More Strengths of Actonel
June 2015 - Teva has begun shipping risedronate tablets in 5mg, 30mg and 35mg strengths. Risedronate, the generic of Actonel®, manufactured by Actavis, is indicated to prevent and treat osteoporosis for postmenopausal women and patients who use corticosteroids to treat other conditions. Risedronate is also used to treat men with osteoporosis and patients with Paget’s disease. For osteoporosis, the 5mg tablet is taken daily; the 35mg is used weekly. Paget’s disease patients take 30mg daily for two months followed by two months off of active treatment, which may be repeated if needed. Teva was the first company to file for generic approval therefore it has 180 days of exclusivity on all three strengths. Generics to the once-month Actonel 150mg tablets became available in June 2014. According to IMS Health, U.S. sales of Actonel were $157 million in 2014.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.