Novadoz/MSN Labs’ generic Lyrica gets FDA clearance

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Novadoz/MSN Labs’ generic Lyrica gets FDA clearance

By Sandra Levy - 08/20/2019
Novadoz Pharmaceuticals, the sales and marketing affiliate for MSN Labs, was among the nine generics firms that recently received the Food and Drug Administration’s approval for a generic version of Pfizer’s Lyrica capsules.

Novadoz pregabalin capsules are available in dosage strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg in 90-count bottles, with bulk sizes slated for after its launch.

Pregabalin is indicated for epilepsy, neuropathic pain, fibromyalgia, and restless leg syndrome. It also is used to treat epilepsy as adjunctive therapy for partial seizures.

The brand has a market value of roughly more than $5.4 billion, the company said.

“The approval for Pregabalin, one of the largest generic industry launches in past several years, was a tremendous accomplishment for our entire organization. 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,” said Seshu Akula, Novadoz president North America generics said.

Tom DeStefano, Novadoz vice president of sales and marketing, said, “The scope and size of the product require 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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