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Glenmark Pharma receives USFDA approval for urea cycle disorder drug

Glenmark Pharma receives USFDA approval for urea cycle disorder drug

Glenmark Pharma receives USFDA approval for urea cycle disorder drug
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By CNBCTV18.com Nov 2, 2022 1:17:03 PM IST (Published)

The drug will be distributed by Glenmark Pharmaceuticals Inc. in the United States.

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Glenmark Pharmaceuticals' Abbreviated New Drug Application (ANDA) has received approval by the United State Food and Drug Administration (USFDA), the company said in an exchange filing.
The approval is for Sodium Phenylbutyrate Tablets USP 500 mg. This is the generic version of Buphenyl Tablets 500 mg of Horizon Therapeutics LLC.
Sodium Phenylbutyrate is used for the treatment of patients with urea cycle disorders (UCDs). The drug helps to prevent the accumulation of ammonia in the blood.
An abbreviated new drug application (ANDA) is submitted to the FDA for the review and potential approval of a generic drug product. Post the approval, Glenmark can manufacture and distribute Sodium Phenylbutyrate tablets in the US market.
The drug will be distributed by Glenmark Pharmaceuticals Inc. in the United States.
The Buphenyl tablets market achieved annual sales of nearly $8.7 million, according to the IQVIA sales data for the 12-month period ending September 2022.
Glenmark Pharma also launched Fingolimod capsules in the US market on November 1. The drug is used in the treatment of multiple sclerosis in patients aged 10 and above.
Glenmark Pharma’s current portfolio includes 177 products authorised for distribution in the US market. Another 46 abbreviated new drug applications (ANDA) are pending with USFDA for approval.
Glenmark has a presence across specialty, generics, and over-the-counter (OTC) businesses. The company has 10 manufacturing facilities spread across four continents and operations in over 80 countries.
Shares of Glenmark are trading 1.4 percent higher at Rs 419.30.
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