Generic Azilect Approved
March 17, 2016 – The U.S. Food and Drug Administration approval of rasagiline was announced by its manufacturer, Orchid Pharmaceuticals. Rasagiline, is the company’s first AB-rated generic for Azilect (Teva Neurosciences) tablets, indicated for the treating of Parkinson’s disease. The drug works by blocking the activity of monoamine oxidase-B (MAO-B), an enzyme that breaks down dopamine, which therefore helps to stabilize blood levels of dopamine. It is important that dopamine levels are regulated because low dopamine levels, may lead to problems with balance, movement, muscle control, and other symptoms of Parkinson’s. The recommended dose of Rasagiline for the treating of Parkinson’s is once daily either alone or in combination with levodopa, another Parkinson’s medication. Orchid Phamaceuticals plans to introduce Rasagiline to the U.S. market in the third quarter in 2016. Orchid has a 180-day exclusivity period for Rasagiline. Global sales for Azilect in the year 2015, was approximately $514 million, according to Teva Neuroscience’s annual report.
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.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.