Prestalia Approved to Treat Hypertension
The U.S. FDA approved Prestalia (perindopril arginine/amlodipine), a combination product used to treat high blood pressure, manufactured by Symplmed Pharmaceuticals. Prestalia contains 3.5mg of perindopril arginine, an angiotensin converting enzyme (ACE) inhibitor, and 2.5mg of amlodipine, a calcium channel blocker.
Prestalia can be used as initial treatment or it can be used when one drug alone is not enough to control blood pressure. The launch of Prestalia is planned for the first quarter of 2015 and will be exclusively through bpCareConnect, Symplmed’s members-only hypertension management program. Prestalia labeling carries a Boxed Warning regarding the risk of fetal toxicity.
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.