FDA Approves Mylan's Generic Duragesic

The FDA approved Mylan Laboratories' generic version of Johnson & Johnson (J&J) subsidiary Alza's Duragesic pain patch, the same day it denied citizen's petitions that had attempted to block generic entry to the Duragesic market.

Mylan recently announced that the FDA had granted final approval to the company's abbreviated new drug application (ANDA) for generic Duragesic (fentanyl transdermal system) in 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr strengths. Mylan said it would begin shipping the product immediately.

Mylan's launch comes just days after J&J's pediatric exclusivity on the product recently expired. Mylan spokeswoman Heather Bresch said this is the first generic Duragesic product to hit the market to her knowledge. Bresch noted, however, that Mylan is not eligible for 180-days of marketing exclusivity under Hatch-Waxman because J&J's patent on the drug and its pediatric exclusivity have already expired.

The same day Mylan received approval for its fentanyl product, the FDA denied four citizen's petitions that Noven Pharmaceuticals alleged were a coordinated campaign to block its generic Duragesic candidate.

Noven filed a complaint with the FDA in late December, alleging that a "suspicious" string of citizen's petitions were a deliberate attempt to derail the company's ANDA for a fentanyl product. The petitions were filed by Alza, law firm London & Mead and three physicians.

The FDA rejected the petitions, clearing the way for a decision to be made on Noven's ANDA. Noven did not indicate when it expects the application to be approved.