Aurobindo Pharma gets USFDA nod for its expectorant tablets

Aurobindo Pharma recently 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 $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.