Generic drug makers announce FDA approval for Zyrtec
ALLEGAN, Mich. Like Claritin before it, Zyrtec will be faced with private-label competition not too long after reaching store shelves. Mylan, Perrigo and Caraco Pharmaceutical on Friday separately announced that they have received final approval from the Food and Drug Administration for their abbreviated new drug application, for over-the-counter cetirizine, 5 mg and 10 mg.
The products will be comparable to McNeil Consumer Healthcare’s Zyrtec, indicated for allergy and hives relief, which is expected to reach store shelves Jan. 24.
According to Wolters Kluwer data provided by Perrigo, brand sales for the original prescription strength version of the product for the 12 months ending October 2007 were approximately $1.4 billion.
Brand sales for comparable Claritin and Claritin D were a combined $285.9 million for the 52 weeks ending Oct. 7 across food, drug and mass (excluding Wal-Mart) channels, according to Information Resources, Inc.
Medtech, Pharmaspray enter into manufacturing agreements
IRVINGTON, N.Y. Medtech Products, a subsidiary of Prestige Brands Holdings, last week entered into two contract manufacturing agreements with Pharmaspray according to SEC documents filed Thursday.
Medtech signed Pharmaspray to a three-year deal for Pharmaspray to be the exclusive manufacturer of the Wartner and Compound W Freeze Off brands, respectively, that are distributed in certain markets designated in the contracts.
Bayer recalls glucose meter test strips
TARRYTOWN, N.Y. Bayer Diabetes Care last week initiated a voluntary market recall of test strips used exclusively with the Contour TS Blood Glucose Meter.
In the course of its routine quality control monitoring processes the Bayer identified a manufacturing issue with test strips from specific lots that could result in blood glucose readings with a positive bias that is outside of product specifications. Test results may demonstrate results between 5 percent and 17 percent higher, the company reported.
This issue is unrelated to the Contour TS meter itself and pertains only to certain test strips used with the meter, Bayer clarified. Additionally, this issue has no impact on the performance of strips used with other Bayer meters including Ascensia Contour and Ascensia Breeze2 systems, the company said.
Healthcare providers, retailers, patients and other customers who use Contour TS are advised to check the lot number on the bottles of Contour TS strips and to contact Bayer Diabetes Care for information regarding return and replacement of strips. The affected lots begin with WK followed by the characters 7D, 7E, 7F or 7G and then followed by a series of other numbers and letters (for example WK7ED3E52C). Only bottles of test strips with the characters 7D, 7E, 7F, or 7G in the third and fourth position in the sequence are affected.
In the U.S., the affected product code numbers include: 1802, 1802N, 1820, 1823, 1825 and 9578.