Ranbaxy Wins FDA Approval for Generic Anti-Infective

The FDA has given the all-clear for Ranbaxy Pharmaceuticals to manufacture and market doxycycline tablets 50mg, 75mg and 100mg – the bioequivalent of Bioglan Pharmaceutical’s branded anti-infective Adoxa.

Doxycycline is indicated for a variety of infections when caused by susceptible strains of microorganisms, including respiratory tract and urinary tract infections, skin and skin structure infections, and severe acne as adjunctive therapy.

According to sources quoted by the company, annual market sales for Adoxa were $57.2 million.

“Ranbaxy is pleased to receive this most recent approval from the US FDA. Doxycycline will add to our ever-expanding product portfolio of affordable generic alternatives that will have a positive effect on the economics of healthcare,” said Jim Meehan, VP of sales and marketing for Ranbaxy.

Ranbaxy Pharmaceuticals based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories, India’s largest pharmaceutical company.