The company also received US FDA approval to market Nitrofurantoin Capsules USP to treat urinary tract infections
Cadila Healthcare has received approval from the US health regulator to market Pramipexole Dihydrochloride extended-release tablets, used for treating Parkinson’s disease, in the American market.
The company’s subsidiary, Zydus Pharmaceuticals (USA) Inc, has received the final approval from the US FDA to market Pramipexole Dihydrochloride extended-release tablets in strengths of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg and 4.5 mg, Cadila Healthcare said in a statement.
The drug is indicated to treat signs and symptoms of Parkinson’s disease (PD). The Ahmedabad-based firm also received final approval from the US FDA to market Nitrofurantoin Capsules USP, used for treating acute uncomplicated urinary tract infections, in the US market. Both the drugs will be manufactured at Zydus group’s formulations manufacturing facility at Moraiya, Ahmedabad.