Mumbai: Drug firm Aurobindo Pharma has received US regulatory approval to manufacture and market Alendronate Sodium tablets, used in the treatment of bone diseases, in that country.
“The company has received final approval from the US Food and Drug Administration (US FDA) to manufacture and market Alendronate Sodium tablets in variants of 10 mg, 35 mg and 70 mg,” Aurobindo Pharma said in a filing to the Bombay Stock Exchange.
“Alendronate Sodium tablets, used in the treatment of Osteoporosis, are generic equivalent to Merck & Co’s Inc Fosamax tablets of variants in 10 mg, 35 mg, 70 mg,” it added.
“The approval came within eight months of the date of filing with the US FDA. With this, the number of Abbreviated New Drug Application (ANDA) approvals from the US FDA stands at 73,” the filing added.
“Aurobindo got the US FDA nod on the first day of the expiry of the relevant patent and the product will be launched immediately in the US market,” the company said.
Shares of Aurobindo were trading at Rs306, up 1.12% in the afternoon trade on the BSE.