Aurobindo Pharma wins USFDA nod for generic version of Mucinex Tablets

Guaifenesin extended-release tablets are the generic version of RB Health (US) LLC's Mucinex tablets, Aurobindo Pharma said.

New Delhi: Drug firm Aurobindo Pharma on Thursday said it has received the 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.

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"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.

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