Unichem Laboratories said that it has secured a tentative approval for abbreviated new drug application (ANDA) of Aripiprazole Tablets, USP, 2mg, 5mg, 10mg, 15mg, 20mg, and 30mg from the US Food and Drug Administration (USFDA).
Aripiprazole Tablets, USP is a generic version of ABILIFY (Aripiprazole Tablets) owned by Otsuka Pharmaceutical.
The drug is approved for use in patients with schizophrenia, irritability associated with autistic disorder, and also Tourette’s disorder.
Unichem Laboratories said that the product will be commercialized from its Ghaziabad factory after receipt of full approval from the FDA.
In May 2021, the Indian specialty pharma company had been given approval from the FDA for the ANDA of its Amitriptyline HCl Tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg.
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