Generics to Minastrin 24 FE Chewable Tablets Now Available
March 16, 2017 – Lupin announced the launch of its A-rated generics to Minastrin® 24 Fe chewable tablets. The oral contraceptive 28-day pack contains 24 norethindrone acetate and ethinyl estradiol (1mg / 0.02mg) chewable tablets and four non-hormonal ferrous fumarate tablets (75mg). While approved by the FDA in May 2016, Lupin has now launched its generic with the trade name of Mibelas 24 Fe. Teva also launched an authorized generic to this product, which is essentially the brand drug repackaged into generic-looking packaging. According to IMS Health, Minastrin 24 Fe chewable tablets had U.S. sales of approximately $360 million for the 12 months ending December 2016.
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 U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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 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.