MYLAN RECEIVES APPROVAL FOR GENERIC DITROPAN XL, ADOXA

Mylan Laboratories announced that the FDA has granted final approval to Mylan Pharmaceuticals's abbreviated new drug application (ANDA) for oxybutynin chloride extended-release tablets, 5 and 10 mg. The company also received final approval for its ANDA for doxycycline tablets, 50, 75 and 100 mg. The company said it will launch these products immediately.

Oxybutynin chloride is the generic version of Alza's Ditropan XL. Doxycycline is a generic version of Doak Dermatologics' Adoxa, which is manufactured by Par Pharmaceuticals. Doxycycline had U.S. sales of approximately $56 million for the three strengths approved, Mylan said, citing IMS Health.

Ditropan XL is indicated for the treatment of urinary incontinence. Adoxa is a broad-spectrum antibiotic indicated for the treatment of various bacterial infections, such as those caused by some gram-negative microorganisms, including Staphylococcus aureus and Bacillus anthracis (anthrax), and as an adjunctive therapy for severe acne.

Mylan is the first generic drug company to file ANDAs for 5- and 10-mg oxybutynin chloride extended-release tablets, so the company has 180 days of market exclusivity for those strengths. The company has entered into an agreement with Alza that ensures Mylan will be able to launch the 15-mg tablet when possible.