The Food and Drug Administration on Thursday announced it required Sunovion Pharmaceuticals, manufacturer of the sleep drug Lunesta (eszopiclone), to change the drug label and lower the current recommended starting dose.
The stampede of big-selling branded medicines that hurtled off the patent cliff in 2011 and 2012 has slowed to a relative trickle.
Teva Pharmaceutical Industries announced the launch of a generic equivalent to Lunesta (eszopiclone tablets) in 1-,2- and 3-mg form in the United States.
Sunovion Pharmaceuticals on Monday announced that Aptiom (eslicarbazepine acetate), a once-daily antiepileptic drug, is now available across the United States.
The Food and Drug Administration has approved a drug made by Sunovion and Dainippon Sumitomo Pharma Co. for bipolar disorder, Sunovion said.
A federal appellate court has ruled in favor of Mylan in a case involving a drug for chronic obstructive pulmonary disease, the drug maker said.
Teva Pharmaceutical Industries has launched a generic inhaler used to treat bronchospasm, the company said.
The Food and Drug Administration has approved a generic treatment for bronchospasm made by Mylan, the drug maker said Monday.