Aurobindo obtains FDA OK for 2 generics

Generic Sinemet is used to treat Parkinson’s disease; generic Valcyte is used for the prevention of Cytomegalovirus disease in kidney and heart transplant patients at high risk.
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Aurobindo has received the Food and Drug Administration’s blessing for two generics.

The company has received the nod for carbidopa and levodopa tablets 10 mg/100 mg, 25 mg/100 mg and 25 mg/250 mg.

The medication is the generic of Organon’s Sinemet.

Carbidopa and levodopa tablets are indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.

Carbidopa and levodopa tablets have a market value of roughly $80.2 million for the 12 months ending September 2022, according to IQVIA.

[Read more: Aurobindo obtains FDA approval for generic Colcrys]

Aurobindo also received the FDA’s clearance for valganciclovir for oral solution, 50mg/ml, which is the generic of Hoffman La Roche’s Valcyte.

Valganciclovir for oral solution is indicated for the prevention of Cytomegalovirus disease in kidney and heart transplant patients at high risk.

The product has a market value of roughly $27.6 million for the 12 months ending September 2022, according to IQVIA.

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