FDA accepts Teva’s sNDA for pediatric QNASL
JERUSALEM — Teva Pharmaeceuticals on Tuesday announced that the Food and Drug Administration accepted the company’s supplemental new drug application for a lower dose QNASL (beclomethasone dipropionate) nasal aerosol, which is used for the treatment of seasonal and perennial allergic rhinitis in children ages 4 years to 11 years.
QNASL, a waterless intranasal corticosteroid spray, is currently available to treat patients 12 years of age and older who show symptoms of seasonal allergic rhinitis and perennial allergic rhinitis, the company notes.
“We are very pleased the FDA has accepted for review the sNDA for QNASL. If the FDA approves the new indication for QNASL, it will become the first waterless HFA nasal allergy treatment approved for patients as young as 4 years of age,” said Tushar Shah, M.D., SVP at Teva Global Respiratory Research and Development. “The low-dose formulation demonstrates our commitment to the development of innovative treatment options for all patients with respiratory conditions, including nasal allergies.”
Report: Mainstream pharmacy won’t dispense medical marijuana
NEW YORK — Sales of medical marijuana will remain within a burgeoning specialty channel without competition from traditional retail players like CVS Caremark, Rite Aid or Walgreens, Bloomberg Businessweek reported Tuesday.
Though more than 21 states have legalized marijuana for medical use, according to the report, pharmacy operators would violate the registrations with the Drug Enforcement Agency that enables them to dispense controlled substances.
At the federal level, marijuana is classified as a Schedule I drug, making it illegal to prescribe or dispense, the report noted.
McKesson’s fiscal 2014 revenues reach $137.6 billion, up 12.7%
SAN FRANCISCO — McKesson Monday afternoon reported that revenues for the fourth quarter ended March 31 were $38.1 billion, up 25%. “Distribution solutions had another outstanding year with strong performance across the segment," stated John Hammergren, McKesson chairman and CEO. "We continue to deliver tremendous value for our customers through the combination of our industry-leading service, our depth of experience in the healthcare supply chain and our global sourcing expertise.”
For the fiscal year, McKesson had revenues of $137.6 billion, representing a boost of 12.7%. Full-year GAAP earnings per diluted share from continuing operations was $5.83 compared to $5.62 a year ago.
“For the full year, we had strong growth in adjusted earnings, up 31% from the prior year, and a record year for operating cash flow generated by the business," Hammergren said. "These results were driven primarily by outstanding performance in the distribution solutions segment and disciplined working capital management across the company. Additionally, during the fourth-quarter, we secured the acquisition of Celesio which marks an important step for McKesson as we expand to serve our customers and manufacturing partners with global scale.”
Distribution solutions revenues were up 26% for the fourth quarter and up 13% for the full year compared to the prior year. North America pharmaceutical distribution and services revenues, which include results from U.S. Pharmaceutical, McKesson Canada and McKesson Specialty Health, were up 9% for the fourth quarter, primarily reflecting market growth and growth from existing customers. For the full year, North America pharmaceutical distribution and services revenues were up 7% compared to the prior year.
International pharmaceutical distribution and services revenues, which represent the results of Celesio for the two months ended March 31, 2014, were $4.8 billion for the fourth quarter and full year.
Medical-surgical distribution and services revenues were up 28% for the fourth quarter and 57% for the full year driven by the acquisition of PSS World Medical and market growth.
Technology solutions products and services revenues were down 1% for the fourth quarter and up 5% for the full year. “Fourth-quarter Technology solutions revenues were impacted by an anticipated year-over-year decline in our Horizon hospital software business. This revenue decline was partially offset by the solid growth we experienced in our connectivity and payer-focused businesses. Our technology businesses remain focused on innovating for important customer priorities including solutions for value-based reimbursement, business intelligence and analytics, and healthcare data interoperability,” Hammergren said.