Unichem Laboratories gets FDA approval for Sitagliptin Tablets
Unichem Laboratories Limited said that it has secured tentative approval for abbreviated new drug application (ANDA) of Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg from the US Food and Drug Administration (FDA).
The company’s Sitagliptin Tablets is a generic version of Januvia (sitagliptin) tablets, 25 mg, 50 mg, and 100 mg, of pharma giant Merck.
Sitagliptin tablets have approval in the US as an adjunct to diet and exercise for enhancing glycemic control in adults having type 2 diabetes mellitus.
Unichem Laboratories gets FDA approval for Sitagliptin Tablets. Photo courtesy of Anita starzycka from Pixabay.
Unichem Laboratories said that the product will be commercialized from its pharma manufacturing plant in Goa after receiving full approval from the FDA.
Recently, the Indian pharma company had been granted a tentative approval for ANDA of Aripiprazole Tablets, USP, 2mg, 5mg, 10mg, 15mg, 20mg, and 30mg from the FDA.