Impax Laboratories Receives Final FDA Approval for Generic Allegra-D 60mg/120mg Tablets

Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company’s Abbreviated New Drug Application (ANDA) for the generic version of Allegra-D® (Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release) 60mg/120mg tablets. The Company is preparing for product launch through Global Pharmaceuticals, Impax’s generic division.

The FDA awarded Impax 180 days of generic drug exclusivity as it was the first ANDA applicant to submit a substantially complete ANDA with paragraph IV certifications to the 6,399,632, 7,135,571 and 7,138,524 patents, and was one of the first ANDA applicants to submit a substantially complete ANDA with paragraph IV certifications to the 7,662,835 and 7,666,881 patents.

Sanofi Aventis US, LLC, markets Allegra-D for the treatment of the symptoms associated with seasonal allergic rhinitis. According to Wolters Kluwer Health, U.S. branded and generic sales of Allegra-D® 60mg/120mg tablets were approximately $214 million for the 12 months ended September 30, 2010.

About Impax Laboratories, Inc.

Impax Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax has developed marketing partnerships to fully leverage its technology platform. Impax Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward, Philadelphia and Taiwan facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.

"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:

To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include the effect of current economic conditions on the Company’s industry, business, financial position, results of operations and market value of its common stock, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, reductions or loss of business with any significant customer, the impact of competitive pricing and products and regulatory actions on the Company’s products, the ability to sustain profitability and positive cash flows, the ability to maintain sufficient capital to fund operations, the ability to successfully develop and commercialize pharmaceutical products, the uncertainty of patent litigation, consumer acceptance and demand for new pharmaceutical products, the difficulty of predicting FDA filings and approvals, the inexperience of the Company in conducting clinical trials and submitting new drug applications, reliance on key alliance and collaboration agreements, the availability of raw materials, the ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory environment, exposure to product liability claims and other risks described in the Company’s periodic reports filed with the SEC. Forward-looking statements speak only as to the date on which they are made, and Impax undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.

Impax Laboratories, Inc. (delisted) (NASDAQ:IPXL)
Historical Stock Chart
From May 2024 to Jun 2024