Mylan has requested for a temporary restraining order in its lawsuit seeking to stop the FDA from approving any other generic versions of Norvasc, known as amlodipine besylate. Pfizer manufactures the branded Norvasc and is in disagreement with Mylan over when the drug patent expires.
At the request of the FDA, the court extended the deadlines in its previous order by one week so that the FDA is now enjoined from taking final agency action from April 18th until April 20th.
Mylan triggered a 180-day exclusivity period for all strengths of amlodipine besylate when it launched the product on March 23rd.