FDA approves Mylan’s generic Maxalt MLT tablet
PITTSBURGH — Mylan announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for rizatriptan benzoate orally disintegrating tablets, 5 mg and 10 mg, and rizatriptan benzoate tablets, 5 mg and 10 mg. These products are the generic versions of Merck’s Maxalt MLT® Tablets and Maxalt® Tablets, respectively, and are indicated for the acute treatment of migraine with or without aura in adults.
Mylan was the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for rizatriptan benzoate orally disintegrating tablets, 5 mg and 10 mg, and was awarded 180 days of marketing exclusivity.
"Mylan’s immediate launch of the first generic rizatriptan benzoate orally disintegrating tablets, 5 mg and 10 mg, and the company’s simultaneous launch of rizatriptan benzoate tablets, 5 mg and 10 mg, further demonstrates our commitment to continue expanding access to high-quality medicines for patients who need them in the U.S. and around the world. We look forward to continue growing our portfolio of more than 1,100 generic pharmaceutical products to further support this cause," said Mylan CEO Heather Bresch.
Currently, Mylan has 183 ANDAs pending FDA approval, representing $79.9 billion in annual sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $20.8 billion in annual brand sales, for the 12 months ended June 30, 2012, according to IMS Health.
Emergent BioSolutions secures manufacture and sales rights to pandemic influenza vaccine in U.S.
ROCKVILLE, Md. — Emergent BioSolutions on Friday announced that it has signed a license agreement with VaxInnate Corporation under which Emergent acquired the exclusive right to manufacture and sell VaxInnate’s pandemic influenza vaccine candidate in the United States.
The product candidate, a recombinant vaccine, has the potential to be produced quickly, at high yields and in a cost-effective manner, the company stated. This license enables Emergent to fulfill the requirement to secure a pandemic influenza vaccine candidate under its contract with the Biomedical Advanced Research and Development Authority, which established Emergent as a Center for Innovation in Advanced Development and Manufacturing in June 2012.
VaxInnate will continue to develop its pandemic influenza vaccine candidate under its current BARDA contract and Emergent will manufacture the pandemic influenza vaccine candidate using flexible manufacturing technology.
Watson confirms Velcade patent challenge
PARSIPPANY, N.J. — Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the U.S. Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals’ Velcade.
Bortezomib is a proteasome inhibitor for intravenous or subcutaneous administration, approved for treatment of patients with multiple myeloma and patients with mantle cell lymphoma who have received at least one prior therapy.
Millennium filed suit against Actavis on Dec. 21 in the U.S. District Court for the District of Delaware seeking to prevent Acatavis from commercializing its ANDA product prior to the expiration of certain U.S. patents. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis’ ANDA for up to 30 months from the date the plaintiffs received notice of Actavis’ ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
For the 12 months ended Oct. 31, 2012, Velcade had total U.S. sales of approximately $740 million, according to IMS Health.