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Specialty pharmaceutical firm Actavis has reached a deal to market generic versions of Valeant Pharmaceuticals’ acne-treating Acanya Gel, as well as its hypertension drug Tiazac, under a patent settlement agreement announced Monday. Read More
Shire Pharmaceuticals said it will acquire Lumena Pharmaceuticals for at least $265 million, making it the latest drugmaker to turn to new treatments for rare diseases as a means to offset losses from generic competition. Read More
The FDA has been quicker to approve new active substances over the last decade than both its European and Japanese counterparts, a recent study finds. Read More
Sun Pharma is in the midst of another quality problem, this time involving a massive recall of 428,058 bottles of antihistamines and antidepressants after stability testing found issues with the products. Read More
A new Citizen Petition contends the FDA should revoke Ranbaxy’s first-to-file market exclusivity status on several lucrative generic drugs due to a clear history of manufacturing problems and intentional false statements made by the Indian generics company. Read More
The FDA says it will reach out to holders of roughly 375 prescription drug applications filed before June 2001 and ask them to voluntarily adopt the user-friendly labeling format created under the “Physician Labeling Rule.” Read More