Perrigo Announces FDA Approval for Generic Version of NASA... ( ALLEGAN Mich. Aug. ...)

Perrigo Announces FDA Approval for Generic Version of NASACORT(R) AQ

Date:8/3/2009

ALLEGAN, Mich., Aug. 3 /PRNewswire-FirstCall/ -- Perrigo Company (Nasdaq: PRGO; TASE) today announced that its partner Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) (previously Barr Laboratories Inc.) has received final approval from the U.S. Food and Drug Administration to market Triamcinolone Acetonide Nasal Spray containing a paragraph IV certification. Perrigo's partner Teva was the first applicant to file a complete ANDA with a Paragraph IV certification for NASACORT AQ. The product was developed at Perrigo.

Under the terms of a previously disclosed settlement, Teva will be able to market the ANDA product which is manufactured by Perrigo under license from Sanofi-Aventis commencing on June 15, 2011. Perrigo will share in the costs and benefits in Teva's marketing of the products under the agreement.

The product is the AB-rated equivalent to Sanofi - Aventis' Nasacort(R) AQ, indicated for the treatment of the nasal symptoms of seasonal and year round allergies in adults and children six years of age and older. Sales for the brand were approximately $305 million, according to Wolters Kluwer data for the twelve months ending June 2009.

Perrigo's Chairman and CEO Joseph C. Papa concluded, "This approval is a terrific example of Perrigo's strategic focus on developing challenging products in the extended topical categories. It further demonstrates our strategy to deliver quality affordable healthcare for generic prescriptions and over the counter products."

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) an
'/>"/>

0

GOOD

Page: 1 2 3
Related medicine news :

1. Perrigo Receives FDA Approval to Market Cherry and Cinnamon Flavored Nicotine Lozenges
2. Perrigo Confirms That its Partner Synthon Has Filed for Generic Version of Xyzal(R) Solution and Announcement of Lawsuit by Sepracor/UCB
3. Perrigo Reports Record Third Quarter
4. Perrigo Company Announces Quarterly Dividend
5. Perrigo Announces FDA Approval for Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion)
6. Perrigo Begins Shipments of Ibuprofen PM
7. Perrigo Reports Record Second Quarter Sales
8. Perrigo Company Announces Quarterly Dividend
9. Perrigo Company Appointed Generic Distributor by Medimetriks Pharmaceuticals
10. Perrigo Company Will Release Second Quarter Fiscal Year 2009 Results on February 3, 2009
11. Perrigo Company to Present at the 27th Annual JPMorgan Healthcare Conference

Post Your Comments:

Perrigo Announces FDA Approval for Generic Version of NASA...( ALLEGAN Mich. Aug. ...),Health