FDA gives nod, tentative OK for Lupin's 2 genericsLupin has received the Food and Drug Administration's OK for generic Onfi, and tentative nod for generic Adcirca, with a value of $601.2 million and $503.8 million, respectively. Vitruvius Therapeutics gets FDA nod for generic AmicarVitruvius recently received the FDA's approval for generic Amicar, which has a market value of roughly $26.2 million. Mylan launches generic Lialda The Food and Drug Administration has approved Mylan's generic Lialda, which had a market value of roughly $842 million for the year ended Oct. 31, according to IQVIA data. FDA gives Lupin’s generic Tecfidera tentative approval Lupin has received tentative approval for generic Tecfidera, which had a market value of about $3.5 billion. FDA pulls generics labeling proposed rule The FDA has withdrawn a 2013 proposed rule that would have allowed generic drug makers to independently update drug labels. FDA issues new guidances to advance biosimilars The Food and Drug Administration said it expects to focus on preventing potentially anti-competitive practices for biosimilar drugs. Lupin introduces generic Rapaflo Lupin rolls out generic Rapaflo, which had a market value of about $198.5 million. FDA gives Lupin's generic Eliquis tentative approval The FDA has given tentative clearance for Lupin's generic Eliquis, which had a market value of about $6.4 billion. Hikma launches generic Onfi Hikma is offering clobazam oral suspension and clobazam tablets, which had a market value of $260 million and $601 million respectively. Sun Pharma gets FDA green light for generic Ganirelix The Food and Drug Administration has cleared Sun Pharma's generic Ganirelix, which had a market value of about $67 million, according to IQVIA data. First Previous 187 188 189 190 191 Next Last