Glenmark and Lupin gain FDA approval for nervous system agents

Generics/News | Posted 08/11/2019 post-comment0 Post your comment

Indian generics maker Glenmark Pharmaceuticals has been granted tentative US Food and Drug Administration (FDA) approval for its multiple sclerosis (MS) generic, while generics giant Lupin Ltd has also received FDA approval for its Dilantin generic, an anti-seizure medication.

Multiple Sclerosis V14A24

Glenmark has received tentative approval from FDA for delayed release Dimethyl Fumarate capsules in two formulations, 120 mg and 240 mg.

The drug is a generic version of Biogen’s Tecfidera, which has been used to treat relapsing MS since 2013 and achieved sales of almost US$4 billion for the company for the year ending August 2019.

The generic version will add to Glenmark’s existing portfolio of 161 products in the US (along with another 49 awaiting approval).

The news follows the approval of another MS treatment for Glenmark, a generic version of Aubagio (teriflunomide), back in November 2018 [1]. And expanding into the dermatology market, Glenmark recently received three FDA approvals for its generic versions of Zytiga, DermOtic oil and Qudexy XR [2].

In related news, in October 2019 India-based generics manufacturer Lupin received approval for their generic version of Pfizer’s Dilantin (phenytoin), which is an anti-seizure treatment.

The company received FDA approval for 100 mg phenytoin sodium capsules, indicated for the prevention and treatment of tonic-clonic and focal seizures, which may occur spontaneously or be associated to neurosurgery.

Lupin have also received approval for generic levothyroxine sodium tablets at a range of doses. Levothyroxine is very commonly prescribed for the treatment of hypothyroidism and in the management of thyroid cancer patients.

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1. GaBI Online - Generics and Biosimilars Initiative. Glenmark gains FDA approval for MS and pneumonia generics []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 8]. Available from: 
2. GaBI Online - Generics and Biosimilars Initiative. Three FDA approvals for Glenmark as it enters US branded dermatology market []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 8]. Available from: 

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Source: Glenmark; Lupin

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