HAYWARD, Calif.--(BUSINESS WIRE)--Impax Laboratories, Inc. (NASDAQ: IPXL) today confirms that it has initiated a challenge of the patents listed in connection with JALYN® (dutasteride and tamsulosin hydrochloride 0.5 mg/0.4 mg) capsules. Impax filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of JALYN® with the U.S. Food & Drug Administration (FDA). Following receipt of the notice from FDA that Impax’s ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owner of its paragraph IV certification. Impax and its partner Banner Pharmacaps jointly developed the product.
