Delalutin Generic Approved
October 2015 - The U.S. Food and Drug Administration (FDA) approved McGuff Pharmaceutical’s generic version Delalutin (hydroxyprogesterone caproate injection, 250 mg/mL). Delalutin, manufacturer by Bristol-Myers Squibb, had been previously available as a brand name medication to treat a wide variety of conditions, including advanced adenocarcinoma of the uterine corpus (stage 3 or 4) and the management of amenorrhea and abnormal uterine bleeding. However, Bristol Myers Squibb discontinued marketing of Delalutin in 1999, but because the product was not withdrawn from the market for reasons of safety or efficacy, the FDA is able to approve a new generic. Although pricing information is currently unknown, McGuff Pharmaceuticals is planning to launch the new generic version of Delaultin in 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 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. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.