FDA is not ready to pursue authority to approve follow-on biologics
WASHINGTON Food and Drug Administration spokesperson Christopher Kelly recently said that, despite comments from an agency official on Monday, the agency will not submit to Congress a legislative proposal to seek authority to approve generic versions of biotechnology medications, CongressDaily reports.
FDA chief operating officer John Dyer had said on Monday that the agency had begun to draft language for such a proposal. In addition, a congressional aide said that the FDA informed the House Energy and Commerce Committee about plans to submit such a proposal but did not disclose a timeline.
Kelly said that the comments from Dyer resulted from a misunderstanding. Fiscal year 2009 budget documents refer to a legislative proposal that will provide recommendations on an FDA approval process for generic versions of biotech medications. Kelly said that the reference to such a proposal was an “expression by FDA of our interest in moving this forward, not an actual proposal.”
Parata launches PACMED C30 packaging technology
DURHAM, N.C. Parata Systems has launched its new product, the PACMED C30, which is a packaging technology used to extend the safety and convenience of its onePAC packaging system.
onePac is a strip that contains information like patients’ medications, patient names, pill descriptions and time of day to take a dose of the medication. On the strip, up to 19 lines of information can be held. The goal of the strips are to remind patients who take multiple medications when to take what medications and how much of each medication.
The PACMED C30 expands on the technology of the onePAC by combining multiple onePAC strips together for easy access by patients. PACMED C30 is efficient and accurate, generating up to 60 unit-dose or 50 multi-dose packages a minute.
“Adherence is a critical touch point in the circle of pharmacy care, and Parata’s launch of PACMED C30 offers an exciting new way for pharmacies to extend their care by improving patient adherence, safety and convenience,” says Tom Rhoads, executive vice president for customer and market strategies at Parata Systems.
Teva announces availablility of generic Fosamax
NORTH WALES, Pa. Teva has announced the introduction and availability of alendronate sodium tablets.
This is the generic version of the osteoporosis drug Fosamax by Merck. The drug will be available in 5 mg, 10 mg, 35 mg, 40 mg and 70 mg strengths.
“Our customers count on Teva for a continuous supply of new generic products,” stated John Denman, vice president of sales and marketing. “With the launch of alendronate sodium tablets, we add another quality product to our broad line of affordable generic pharmaceuticals.”