Acticlate Generic Approved
June 14, 2017 – The U.S. FDA has approved Mayne Pharma Group’s generic to Aqua Pharmaceuticals’ Acticlate® (doxycycline hyclate). The generic doxycycline hyclate tablets will be available in 75mg and 150mg dosages. Although a number of generic doxycycline products are already on the U.S. market, Mayne’s are the first for Acticlate. Doxycycline is an antibiotic indicated to treat numerous bacterial infections, including anthrax, cholera and some eye, respiratory, sexually-transmitted, and urinary infections. The 75mg and 150mg tablets are primarily marketed, in combination with other therapy, to treat severe acne. Annual U.S. sales for Acticlate through the end of April 2017 were approximately $250 million, according to QuintilesIMS. Mayne will have 180-day exclusivity.
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.