US health regulators have given the thumbs-up to Mylan and partner Forest Laboratories for their new blood pressure drug nebivolol.

The Food and Drug Administration have granted approval for the treatment which will be sold by Forest under the name Bystolic, a Food and Drug Administration statement said. The green light has been given just over a fortnight after the two firms received an approvable letter for nebivolol, in which the agency expressed some concerns about a back-up manufacturing facility in Belgium that it recently inspected.

Final approval was “contingent upon satisfactory resolution of these deficiencies” and this has been achieved. Datawise, the New Drug Application included information from more than 2,000 people who received Bystolic during clinical trials which demonstrated that efficacy was similar to that of other approved beta blockers. The most common reported side effects were headache, fatigue, dizziness and diarrhoea.

Mylan licensed the US and Canadian rights to nebivolol from Janssen Pharmaceutica in 2001, while Forest signed a development, sales and marketing deal with Mylan in January 2006. The latter has retained an option to co-promote the product which is already being marketed in more than 50 other countries outside of North America.