Generics
MSN Labs/Novadoz Pharmaceuticals wins US FDA approvals for both generic Solifenacin and Trientine tablets
29 May 2019 -

Novadoz Pharmaceuticals reported on Tuesday the receipt of US FDA approval to market the generic Solifenacin Succinate tablets in 5mg and 10mg tablets in 30 and 90 count bottles for treating symptoms of an overactive bladder, frequent or sudden urination and incontinence.

The company added that the Solifenacin Succinate tablets is the generic version of Astellas Pharma's product VesiCare.

According to the company, the US FDA approval for the Solifenacin Succinate is reportedly part of a DAY one launch that marked the brand's patent expiration. The US sales of Solifenacin have exceeded USD940m over the previous 12 months.

Additionally, the company received US FDA market clearance for Trientine Hydrochloride in 250mg capsules in 100 count bottles, which is the company's AB rated generic to Valeant Pharmaceuticals brand Syprine. The product is prescribed to treat Wilson's Disease for patients who cannot tolerate penicillamine. It is a condition where the body stores excess copper. The total market for Trientine over the previous 12 months exceeded USD124m.

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

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