Synovics files ANDA for 10mg Atarax with FDA
USA-based specialty drugmaker Synovics Pharmaceuticals says that its whollyowned subsidiary, ANDAPharm, has filed an Abbreviated New Drug Application with the US Food and Drug Administration, seeking approval for a 10mg dose of its antihistamine Atarax (hydroxyzine HCl).
John Copanos, ANDAPharm chief executive, said that the filing, which is the firm's first for a prescription drug, marked an important step towards improving its product portfolio. He went on to say: "we are in the process of completing and filing follow-on ANDA for 25mg and 50mg doses of this product."
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