Indian drug maker Wockhardt has been charged by the Food and Drug Administration with utilizing the same unapproved method to test drug quality in its Morton Grove, Ill., facility as two facilities in India, both of which were subsequently banned from importing into the United States,the Wall Street Journal reported Tuesday.
Mylan announced on Monday that it has entered into a settlement and license agreement with Pfizer relating to Mylan's abbreviated new drug application filed with the U.S. Food and Drug Administration for celecoxib capsules in 50-mg, 100-mg, 200-mg and 400-mg strengths.
Teva Pharmaceutical Industries on Monday announced a new organizational structure and executive positions. The changes, which will become effective July 1, are designed to improve global integration and effectiveness across the company, Teva said.
Mission Pharmacal on Thursday announced that it has begun the promotion of Elestrin (estradiol gel) 0.06% in the United States through an agreement with Meda AB. The drug is a used as a topical hormone replacement gel to help treat hot flashes caused by menopause.
Teva Pharmaceutical Industries announced on Friday that the U.S. District Court for the Northern District of West Virginia has denied a motion filed by Mylan and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex (celecoxib) 100-, 200- and 400-mg capsules.
As a key Congressional committee is set to consider legislation to help identify solutions for prescription drug abuse while preserving patients’ legitimate access to needed medications, the National Association of Chain Drug Stores has sent a letter to the bipartisan leadership of the House Energy and Commerce committees’ Health subcommittee affirming support for this effort, NACDS has announced.
Nowhere is the value of solid preparation and training more evident than in the fast-evolving world of health care and community pharmacy.
The rapid expansion of pharmacy-based clinical care programs and patient engagement efforts has elevated the need for pharmacists to mentor student pharmacists as preceptors. And it’s made student participation in pharmacy practice rotations and residencies a critical part of the professional education process, as those students prepare for a career in a reforming health system in desperate need of expanded front-line patient care services from pharmacists.
A series of new clinical studies released Tuesday found that Cardinal Health Specialty Solutions’ Clinical Pathways program reduces the cost of cancer treatment, improves clinical care and shows promise for guiding treatment of other high-cost, complex diseases beyond cancer.
Prasco Labs on Thursday announced it has entered into a distribution and supply agreement with Recordati Rare Diseases for the rights to distribute ibuprofen lysine injection, the authorized generic version of NeoProfen (ibuprofen lysine).