Actavis seeks approval for generic testosterone-replacement drug
DUBLIN — Drug maker Actavis hopes to become the first to market with a generic version of a topical testosterone replacement drug marketed by Eli Lilly, Actavis said.
The generic drug maker it filed with the Food and Drug Administration for approval of testosterone topical solution in the 30-mg-per-1.5 mL strength, a generic version of Lilly’s Axiron. The drug is used as a replacement therapy for deficient or absent testosterone.
In response to the filing, Lilly and another company, Acrux, filed a patent-infringement suit against Actavis in the U.S. District Court for the Southern District of Indiana. The lawsuit puts an automatic stay of FDA approval on Actavis’ product for 30 months or until the companies settle the case. Actavis said it was the first company to file for FDA approval and expects to have 180 days in which to compete directly against Lilly’s product upon approval.
Axiron had sales of about $257 million during the 12-month period that ended in September, according to IMS Health.
Upsher-Smith to present phase-3 trial data of experimental epilepsy drug
MAPLE GROVE, Minn. – Drug maker Upsher-Smith Labs will present data from a late-stage trial of a drug for treating epilepsy, the company said Monday.
Upsher-Smith’s presentation of data from a phase-3 clinical trial of USL255 (topiramate extended-release) will take place at the American Epilepsy Society’s 67th annual meeting in Washington, which lasts from Dec. 6-10. Seven presentations will highlight results from the "PREVAIL" trial, while two additional presentations will feature phase-1 trial data on pharmacokinetics of USL255 when sprinkled onto food or swallowed intact.
"This year’s AES meeting marks the first time the findings from our phase-3 trial will be presented publicly," Upsher-Smith chief scientific officer William Pullman said. "We look forward to sharing data from the first global phase-3 clinical trial of an extended-release formulation of topiramate with the epilepsy community at this year’s annual meeting."
N.J. specialty pharmacy wins URAC accreditation
NEW YORK — URAC has granted accreditation to Parkway Pharmacy, a specialty pharmacy based in New Jersey.
The pharmacy said Monday that it had received URAC’s full Specialty Pharmacy Accreditation. Parkway was established in 2010.
"By applying for and receiving Specialty Pharmacy Accreditation, Parkway Pharmacy has demonstrated a commitment to quality health care," URAC COO William Vandervennet said. "Quality health care is crucial to our nation’s welfare, and it is important to have organizations that are willing to measure themselves against national standards."