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Glenmark gains FDA approval for MS and pneumonia generics Posted 07/12/2018

In November 2018, Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced the approval of generics for the treatment of multiple sclerosis (MS) and pneumonia.

Glenmark announced on 16 November 2018 that it had gained US Food and Drug Administration (FDA) approval on 15 November 2018 for its teriflunomide tablets, 7 mg and 14 mg. Glenmark’s product is a generic version of MS treatment Aubagio (teriflunomide) made by Sanofi-Aventis.

According to IQVIA sales data for the 12-month period ending September 2018, Aubagio tablets in dosages of 7 mg and 14 mg market had annual sales of approximately US$1.6 billion.

Then on 22 November 2018, Glenmark announced that it had received FDA approval on 21 November 2018 for its atovaquone oral suspension USP*, 750 mg/5 mL. Glenmark’s product is a generic version of GlaxoSmithKline’s pneumonia treatment Mepron.

According to IQVIA sales data, the Mepron had annual sales of approximately US$119.1 million.

Glenmark says that its current portfolio includes 144 products authorized for distribution in the US and 55 abbreviated new drug applications (ANDAs) pending approval with FDA.

*A USP mark on a medicine indicates to pharmacists, medical practitioners and patients that the product has been made in accordance with the quality standards of the US Pharmacopeia. The US Pharmacopeia is a reference of uniform preparations for the most commonly used drugs – with tests to ensure their quality, potency and purity.

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Source: FDA, Glenmark

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