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Aurobindo Pharma gets USFDA nod for its expectorant tablets

The company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture its generic Guaifenesin extended-release tablets in the strengths of 600 mg and 1,200 mg.

PTI|
Oct 24, 2019, 04.34 PM IST
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Agencies
Agencies
The company's tablets are the generic version of RB Health (US) LLC's Mucinex tablets.
Drug firm Aurobindo Pharma on Thursday said it has received final nod from the US health regulator for its Guaifenesin extended-release tablets used as expectorant.

The company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture its generic Guaifenesin extended-release tablets in the strengths of 600 mg and 1,200 mg, Aurobindo Pharma said in a filing to the BSE. The product is expected to be launched in the fourth quarter of 2019-20, it added.

The company's tablets are the generic version of RB Health (US) LLC's Mucinex tablets, Aurobindo Pharma said. "The approved product has an estimated market size of USD 301 million for the twelve months ending July 2019, according to IRI database," it added.

Guaifenesin extended-release tablets help to loosen phlegm, and thin bronchial secretions to rid bronchial passageways of bothersome mucus and make coughs more productive, the company said.

The company now has a total of 419 abbreviated new drug applications (ANDA) approvals (392 final approvals including 21 from Aurolife Pharma LLC and 27 tentative approvals) from USFDA, it added. Shares of Aurobindo Pharma were trading 1.31 per cent lower at Rs 470 per scrip on the BSE.

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