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news.Irish specialty pharmaceutical firm Actavis has confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval for marketing Saxagliptin Hydrochloride Tablets, 2.5mg and 5mg.
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The company’s ANDA product is a generic version of AstraZeneca and Bristol-Myers Squibb’s Onglyza, which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
AstraZeneca filed suit against Actavis on 23 May 2014 in the US District Court for the District of Delaware seeking to prevent the Irish firm from commercializing its ANDA product prior to the expiration of US Patent No. 7,951,400.
The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis’ ANDA until 31 January 2017, or final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
If the company’s ANDA for generic version of Onglyza is approved, the product may be entitled to 180 days of generic market exclusivity.
The Irish firm is focused on developing and manufacturing generic, brand, branded generic, legacy brands and over-the-counter (OTC) pharmaceutical products.
The North American branded pharmaceuticals business of Actavis is mainly focused on the Women’s Health, Urology, Gastroenterology and Dermatology therapeutic categories with a strong pipeline of products in several stages of development.