FDA approves Novadoz Pharmaceuticals' generic Gabitril, MSN's manufacturing facility

The Food and Drug Administration has given Novadoz two approvals.

The first approval is for tiagabine tablets, 2 mg, 4 mg, 12 mg and 16 mg.

The product is the generic of Gabitril. Tiagabine is indicated as adjunctive treatment for partial seizures in patients age 12 and older. The medication is being offered in a bottle count size of 30. 

[Read more: MSN/Novadoz intros 4 generics] 

The second approval is for Novadoz corporate entity MSN's new, state-of-the-art, 200,000 sq. ft. manufacturing facility in Piscataway, N.J. Novadoz is the U.S. sales and marketing affiliate for MSN's portfolio of finished dose pharmaceuticals.

This new facility will manufacture high quality, generic pharmaceuticals to include both oral solids and liquids. 

In addition to manufacturing, this facility includes a modern lab and executive offices for both MSN and Novadoz. 

[Read more: MSN Labs obtains FDA OK for two generics]

"We're excited for the team's efforts in receiving final clearance and to begin manufacturing high-quality therapies for patients here in the United States. Having a U.S. manufacturing presence will augment our efforts to expand the Made-in-USA label, reduce supply risk and enable us to support federal supply programs," said Seshu Akula, Novadoz president, North America.