Crestor Available As a Generic
April 28, 2016 – The US Food and Drug Administration (FDA) approved generic Crestor (rosuvastitin calcium) manufactured by Actavis. Crestor is indicated use in combination with diet for treatment of high triglycerides (hypertriglyceridemia) in adults and for treatment of patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia), a disorder associated with improper breakdown of cholesterol and triglycerides. Crestor is also indicated either alone or in combination with other cholesterol treatment(s) for adult patients with homozygous familial hypercholesterolemia, a disorder associated with high low-density lipoprotein (LDL) cholesterol.
The most common side effects reported by participants taking Crestor in the clinical trials included headache, pain in muscles (myalgia), abdominal pain, abnormal weakness (asthenia), and nausea. Rosuvastatin calcium should not be used in women who are pregnant or may become pregnant as it may cause fetal harm and should not be used by women who are nursing their infants.
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 1-800-332-0178
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.