Mylan launches generic Reclast injection, Azilect tablets

HERTFORDSHIRE, England and PITTSBURGH — Mylan launched two new product Friday, introducing its generic of Novartis’ Reclast (zoledronic  acid) injection and Teva’s Azilect (rasagiline) tablets, both of which were recently approved by the Food and Drug Administration.

The Reclast generic is distributed in 5 mg/100 ml single dose vials, and is indicated to treat Paget’s disease of the bone in men and women. The drug had U.S. sales of approximately $22.1 million for the 12 months ended March 31, according to QuintilesIMS data.

The generic Azilect tablets are indicated to treat Parkinson’s disease. They will be available in 0.5- and 1-mg dosage strengths, and the product had U.S. sales of roughly $343 million for the 12 months ended March 31, according to QuintilesIMS data.

Mylan said it current has 234 abbreviated new drug applications pending before the FDA and, according to QuintilesIMS, had about $104 billion in annual brand sales.