FDA grants Ranbaxy tentative approval for generic Nexium
PRINCETON Ranbaxy Laboratories has received tentative approval from the Food and Drug Administration for esomeprazole magnesium delayed-release capsules, 20 mg and 40 mg. This is the generic version of AstraZeneca’s drug Nexium.
Nexium is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis, to maintain symptom resolution and healing of erosive esophagitis and for treatment of heartburn and other symptoms associated with Gastroesophageal Reflux Disease.
Ranbaxy believes that it has a First to File status on the drug, providing it with a potential 180 days marketing exclusivity.
Nexium is the second-largest selling drug in the U.S., with total annual market sales of $5.5 billion, according to IMS Health.
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.”