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Amarin Corporation (NASDAQ:AMRN) reported on Wednesday the late December submission of a Supplemental New Drug Application to the FDA which requests approval that BASF be okayed as an additional Vascepa (icosapent ethyl) active pharmaceutical ingredient supplier. The former is a biopharmaceutical firm that is concentrated on the commercialization and development of therapeutics to improve cardiovascular health.
Mylan (NASDAQ:MYL) announced that its subsidiary, Mylan Pharmaceuticals, has won final FDA approval for its Abbreviated New Drug Applications for Rizatriptan Benzoate orally disintegrating tablets, 5 mg (base) and 10 mg (base), and Rizatriptan Benzoate tablets, 5 mg (base) and 10 mg (base). These products represent the generic versions of Merck’s Maxalt MLT Tablets and Maxalt Tablets, respectively, which are indicated for the acute treatment of migraine, with or without aura, in adult patients.
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NuPathe (NASDAQ:PATH) said that the United States Patent and Trademark Office has issued a notice of allowance for Patent application 12/214,555, titled “Polyamine Enhanced Formulations for Triptan Compound Iontophoresis.” This application is connected to methods of treating a migraine by using a triptan with an iontophoretic patch comprised of the firm’s proprietary hydrogel polyamine formulation. NuPathe expects the patent to issue inside the next few months.
On Thursday, Affymax (NASDAQ:AFFY) and Takeda Pharmaceuticals U.S.A. (TKPYY.PK) reported that the J-code assigned by the Centers for Medicare and Medicaid Services for Omontys (peginesatide) Injection is now in effect. This permanent Omontys-specific billing code, J0890, will continue to provide streamlined reimbursement for dialysis organizations that prescribe the injection, representing the once-monthly erythropoiesis-stimulating agent for anemia domestically available to the adult dialysis patient population with chronic kidney disease.
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