americanpharmaceuticalreviewJuly 29, 2019
Tag: FDA , Pregabalin Capsules , Novadoz
Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, has received FDA approval for their generic version of Pregabalin capsules. The patent expiration for the brand Lyrica marketed by Pfizer, occurred on July 19, 2019, which cleared the way for the company to begin immediate shipping of the product.
Novadoz Pregabalin capsules are available in 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, and 300mg strength capsules in 90 count bottles, with bulk sizes slated for post launch. Pregabalin is indicated for epilepsy, neuropathic pain, fibromyalgia, and restless leg syndrome. Its use to treat epilepsy as adjunctive therapy for partial seizures. The brand is currently trending over $5.4 BIL USD in published annual sales.
"The approval for Pregabalin, one of the largest generic industry launches in past several years, was a tremendous accomplishment for our entire organization," Seshu Akula, Novadoz President North America Generics, said. "This product will be an important one for Novadoz over the next decade, providing a steady revenue stream while defining our company's ability to be a consistent and reliable supplier to our customers. We are anticipating an additional 10 to 12 product launches over the next 18 months, that continues the bright outlook we have on our future in the U.S market."
"Novadoz's entrance as a DAY 1 supplier of Pregabalin, further elevates our company's status as a generic supplier," Novadoz's, Tom DeStefano, Vice President Sales & Marketing said. "The scope and size of the product requires a highly efficient and well-planned supply chain and manufacturing process. MSN brings this level of competency to this launch, as well as supporting our current business and future product introductions."
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