KV Pharmaceutical Co genitourinary news

FDA denied a Citizen's Petition from KV seeking to prevent the approval of an ANDA for a generic version of Delatuin hydroxyprogesterone caproate. KV claimed that, if approved, Delatuin would be used off label for the same indication for which Makena hydroxyprogesterone caproate from KV is approved - to reduce the risk of preterm birth in pregnant women with a history of at least one spontaneous preterm birth. The company said this would infringe its Orphan Drug exclusivity for Makena. In its denial, FDA said the Orphan Drug Act does not prohibit approval of an application during the exclusivity period "for such drug labeled for different disease or condition." The ANDA was submitted by McGuff Pharmaceuticals Inc., a subsidiary of McGuff Co. Inc. (Santa Ana, Calif.).

FDA originally approved an NDA from Bristol-Myers Squibb Co. (NYSE:BMY, New York, N.Y.) in 1956 for Delatuin. FDA withdrew approval of the NDA in 2000 following a request from the pharma. Delatuin is approved for use in non-pregnant women to treat advanced adenocarcinoma of the uterine corpus; to manage amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer; as a test for endogenous estrogen production and for the production of secretory endometrium and desquamation. ...