April FDA Pipeline
April FDA Pipeline
Approvable idesignations
Fast-track designations
Nonapprovable designations
A new dosage strength of the fentanyl transdermal system (Duragesic, Alza) was approved for the management of persistent, moderate-to-severe chronic pain requiring continuous opioid administration for an extended period of time that cannot be managed by other drugs. The new patch will deliver 12 mcg of fentanyl per hour.
FDA approved a 40-mg powder for oral suspension formulation of omeprazole (Zegerid, Santarus/Otsuka). The new formulation is indicated for the reduction of risk of upper GI bleeding in critically ill patients and for the short-term treatment (4–8 wk) of active benign gastric ulcers.
FDA approved a new high-potency fluocinonide cream (Vanos, Medicis) for the once- or twice-daily treatment of plaque psoriasis.
The manufacturers of somatropin (rDNA origin) for injection (Tev-Tropin, Teva/Savient) have announced the launch of the growth hormone product for the treatment of children with short stature due to growth hormone deficiency.
FDA granted full approval for doxorubicin liposome injection (Doxil, Tibotec Therapeutics) in the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.
A new aqueous solution formulation of oxaliplatin (Eloxatin, Sanofi-Aventis) was approved for the treatment of colorectal cancer.
FDA approved an intravenous immune globulin (Vaccinia Immune Globulin [VIGIV], Computer Sciences) to treat rare adverse reactions to smallpox vaccination.
FDA Actions in briefA new dosage strength of the fentanyl transdermal system (Duragesic, Alza) was approved for the management of persistent, moderate-to-severe chronic pain requiring continuous opioid administration for an extended period of time that cannot be managed by other drugs. The new patch will deliver 12 mcg of fentanyl per hour.
FDA approved a 40-mg powder for oral suspension formulation of omeprazole (Zegerid, Santarus/Otsuka). The new formulation is indicated for the reduction of risk of upper GI bleeding in critically ill patients and for the short-term treatment (4-8 wk) of active benign gastric ulcers.
FDA approved a new high-potency fluocinonide cream (Vanos, Medicis) for the once- or twice-daily treatment of plaque psoriasis.
The manufacturers of somatropin (rDNA origin) for injection (Tev-Tropin, Teva/Savient) have announced the launch of the growth hormone product for the treatment of children with short stature due to growth hormone deficiency.
FDA granted full approval for doxorubicin liposome injection (Doxil, Tibotec Therapeutics) in the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.
A new aqueous solution formulation of oxaliplatin (Eloxatin, Sanofi-Aventis) was approved for the treatment of colorectal cancer.
FDA approved an intravenous immune globulin (Vaccinia Immune Globulin [VIGIV], Computer Sciences) to treat rare adverse reactions to smallpox vaccination.
David Calabrese of OptumRx Talks New Role, Market Insulin Prices and Other Topics 'On His Mind'
April 13th 2023In this month’s episode of the "What's On Your Mind podcast," Peter Wehrwein, managing editor of MHE connects with the now Chief Clinical Officer of OptumRx Integrated Pharmacies, David Calabrese. In this conversation, David touches on his transition in January as OptumRx’s former chief pharmacy officer and market president of health plans and PBMs to his new role as Chief Clinical Officer where he now focuses more on things such as specialty pharmacy to home delivery — with an overall goal of creating whole-patient care. Throughout the conversation, Calabrese also touched on the market’s hot topic of insulin prices and behavioral health services within the OptumRx community, among other topics.
Listen
Briana Contreras, editor of Managed Healthcare Executive, spoke with Nancy Lurker, CEO and president of EyePoint Pharmaceuticals. Nancy shared a bit about EyePoint and how the organization’s innovative therapies are addressing patient needs through eye care, and most importantly, she addressed C-Suite positions like the CEO role. Nancy shared advice for those seeking to reach the CEO level, especially toward women in healthcare and other roles, and what it takes to run a biopharma company.
Listen
