FDA First Generic Drug Approvals List 2017

first generic drug approvals list

Keeping up with all of the new first generic drug approvals can be a tricky business. On this page, we are dedicated to keeping the list updated and you informed.

(Updated 09/02/17)

27 January 2017 – Amneal Pharmaceuticals LLC, Namzaric (memantine and donepezil hydrochlorides)

 A first generic drug approval has been granted to Amneal Pharmaceuticals LLC to produce Namzaric for the treatment of moderate to severe dementia of the Alzheimer’s type.

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23 January 2017 – Actavis Laboratories FL, Inc. & Aurobindo Pharma Limited, Ampyra (Dalfampridine)

 For those suffering with multiple sclerosis (MS) the first generic drug approval for Ampyra has granted to help improve walking for the patients of the disease.

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17 January 2017 – Roxane Laboratories Inc., Xyrem (Sodium Oxybate Oral Solution)

The first generic drug approval for Xyrem come to the aid of those suffering of cataplexy in narcolepsy; excessive daytime sleepiness (EDS) in narcolepsy.

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4 January 2017 -Aurobindo Pharma Limited,  Ampyra (Levitracetam in Sodium Chloride Injection)

This new FDA first generic drug approval granted to Aurobindo Pharma Limited for an anti-epileptic drug indicated for the adjunct therapy in adults >16 and 16 years of age with certain seizure types when oral administration is temporarily not feasible.

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