Novadoz Pharmaceuticals awarded US FDA approval for generic Pregabalin capsules
24 July 2019 -

Novadoz Pharmaceuticals reported on Tuesday the receipt of the US FDA approval for the generic version of Pregabalin capsules in 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg strength capsules in 90 count bottles, with bulk sizes slated for post launch.

The patent expiration for the brand Lyrica, which is marketed by Pfizer, reportedly overlapped with the day Novadoz began shipping of the product.

According to Novadoz, Pregabalin is indicated for epilepsy, neuropathic pain, fibromyalgia, restless leg syndrome as well as to treat epilepsy as adjunctive therapy for partial seizures.

Currently, the Lyrica brand is trending over USD5.4bn in published annual sales, added the company.

Novadoz Pharmaceuticals is the US based sales & marketing affiliate for MSN Labs, based in Hyderabad India, engaged in the development and manufacturing of API (active pharmaceutical ingredients), KSMs (key starting materials) and product intermediates.