Unichem Laboratories has received ANDA approval from USFDA.
The company has received final ANDA approval for its Pramipexole Dihydrochloride tablets, 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg and 1.5 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Boehringer Ingelheim Pharmaceauticals Inc's Mirapex tablets.
Pramipexole Dihydrochloride tablets are indicated for the treatment of Parkinson's disease and for the treatment of moderate-to- severe primary restless legs syndrome (RLS).
Aurobindo Pharma:
Aurobindo Pharma has received approval from the US health regulator for anaesthesia drug.
The drug maker has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Vecuronium Bromide Injection, 10mg and 20mg.
Vecuronium Bromide is a generic equivalent of Organon's Norcuron injection. "The product will be launched in Q4FY19.
The drug is used as part of general anaesthesia to provide skeletal muscle relaxation during surgery or mechanical ventilation. It is also used to facilitate endotracheal intubation.
The approved product has an estimated market size of $11 million for the twelve months ending September 2018, according to IQVIA.
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