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Glenmark Pharma gets USFDA nod for amphetamine sulfate tablets

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The drug maker on Thursday announced that it has received final approval by the US drug regulator for amphetamine sulfate tablets.

The drug is generic version of Evekeo tablets of Arbor Pharmaceuticals. According to IQVIA sales data for the 12-month period ending November 2020, the Evekeo Tablets, achieved annual sales of approximately $21.5 million.

Amphetamine sulfate tablets are used to treat attention-deficit hyperactivity disorder (ADHD) and a sleep disorder called narcolepsy. It is also used as a short-term treatment, along with a reduced calorie diet and exercise, to help lose weight.

Glenmark's current portfolio consists of 168 products authorized for distribution in the US marketplace and 43 ANDA's pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

 

Shares of Glenmark Pharmaceuticals were trading 0.64% lower at Rs 482.40.

Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across generics, specialty and over-the-counter (OTC) business with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology.

The drug maker's consolidated net profit slipped 8.4% to Rs 233.99 crore on 5.2% increase in net sales to Rs 2,908.12 crore in Q2 September 2020 over Q2 September 2019.

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First Published: Jan 28 2021 | 9:38 AM IST

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