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Glenmark has received USFDA approval for launching generic anti-hypertension drug Nebivolol tablets in the US market for 2.5 mg, 10 mg and 20 mg dosage forms.
Glenamrk has said in a media statement that “With respect to 180 day generic drug exclusivity, the USFDA noted that Glenamrk was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Nebivolol tablets, 2.5 mg, 5 mg, 10 mg and 20 mg.”
It further said that “Therefore, with this approval, Glenmark may be eligible for 180 days of generic drug exclusivity for Nebivolol Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg.”
