AMERIGEN Announces Tentative Approval of Generic Bystolic®
17 Apr, 2015, 09:37 ET
LYNDHURST, N.J., April 17, 2015 /PRNewswire/ -- Amerigen Pharmaceuticals Limited today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Bystolic® (Nebivolol HCl 2.5, 5, 10 and 20mg instant release tablets). Based upon available information, Amerigen believes that it is a first applicant to file an ANDA for Bystolic® containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act.
Forest Laboratories markets Bystolic® in the U.S. for the treatment of hypertension, to lower blood pressure. U.S. sales of Bystolic® were approximately $793 million for the 12 months ended December 31st 2014, according to IMS Health.
Pursuant to a 2013 settlement agreement with Forest Laboratories, and subject to FDA final approval of its ANDA, Amerigen may launch its generic product on the date that is the later of (a) three calendar months prior to the expiration of U.S. Patent No. 6,545,040, including any extensions and/or pediatric exclusivities or (b) the date Amerigen receives final FDA approval of its ANDA, or earlier under certain circumstances.
Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the US and China. The group is controlled by Amerigen Pharmaceuticals Limited. The US regulatory and commercial activities within the group are conducted by Amerigen Pharmaceuticals Inc., based in Lyndhurst, NJ, USA. The group's Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Company Limited, is located in Suzhou, Jiangsu Province. The group has products on the market currently in both the US and China plus an active portfolio of products under development, filed, or intended for filing, as ANDA's with the US FDA and the Chinese CFDA. Amerigen's focus is orally delivered products that are challenging to develop, require specialized technologies or high containment to manufacture, and present complex regulatory and intellectual property obstacles to bring to market. All Amerigen's products are developed and manufactured by the company or its partners around the world to meet the highest quality standards, including the US FDA.
SOURCE Amerigen Pharmaceuticals
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