Slayback gets FDA nod for generic Makena
Slayback Pharma has received the Food and Drug Administration’s clearance for hydroxyprogesterone caproate injection 1,250 mg/5 ml.
Hydroxyprogesterone caproate is a progestin indicated to reduce the risk of preterm birth in women, with a singleton pregnancy, who have a history of singleton spontaneous preterm birth.
The product is the generic of AMAG Pharmaceutical’s Makena (hydroxyprogesterone caproate 1,250 mg/ 5 ml.)
Slayback’s product is available in a 250 mg/ml, 5 ml multidose vial.
“Slayback’s journey has had a singular focus — to develop specialty products, including generics, that are complex; otherwise difficult to develop and/or present other barriers to entry,” Slayback CEO Ajay Singh said. “For many such products, affordable generic options do not exist today because of the inherent technical barriers to entry. Today’s approval is a significant milestone in our journey. We are thrilled and honored to have the opportunity to launch the first approved ANDA for such an important product.”
Teva introduces generic Elidel
Teva Pharmaceuticals is launching pimecrolimus cream in a 1% dosage strength.
The product is the generic of Meda Pharma’s Elidel cream 1%.
It is indicated for the treatment of mild or moderate atopic dermatitis, where treatment with topical corticosteroids is either inadvisable or not possible.
Teva’s generic is available in 30-, 60- and 100-mg tubes.
Students seek broader knowledge base
It used to be that top-notch clinical skills would ensure pharmacy graduates land a high-paying job in retail pharmacy. Yet times have changed. Faced with fierce competition and new models of reimbursement for value-based outcomes, retail pharmacies are looking more closely at pharmacists’ curriculum vitae. Pharmacy grads who also have attained business, technology and leadership skills are likely to have the upper hand.
Realizing that many pharmacy students want to gain business acumen, but are unsure about whether they want to get an MBA, led the University of Wisconsin–Madison School of Pharmacy to create a Pharmacy Operations and Technology Management concentration launched last spring through a partnership with the Wisconsin School of Business’s Erdman Center for Operations and Technology Management, the program enables its PharmD students to devote 12 credits to business electives. Their clinical rotations are business-focused in healthcare management and leadership. In the fourth year of the program, students do a leadership rotation in the community for six weeks.
“With so many pharmacy career paths that require business skills and the growing interest in entrepreneurship, our PharmD students can access essential business training without adding additional time to get their degree, and they still graduate in four years in the PharmD program,” Ed Portillo, assistant professor at the University of Wisconsin–Madison School of Pharmacy, who is leading the new concentration.
Noting that research has shown that 70% of pharmacy managers and those in pharmacy leadership roles are expected to retire in the next 10 years, Portillo said the program helps prepare students to lead.
“The students can go right into high-level leadership positions, and they’ll have the background to drive change in those positions,” he said. They’ll be in a position to do innovative work very early in their career and improve patient outcomes.
Miranda Kozlicki, a third-year PharmD student enrolled in the concentration, said she wanted to get more specialized training in healthcare leadership and management.
“I have the opportunity to work with MBA students that have a wide variety of backgrounds outside of pharmacy, where we focus on how we can provide value to businesses and the patients we serve,” Kozlicki said.