WASHINGTON—The Food and Drug Administration approved the first generic version of the big-selling blood thinner Lovenox, in a victory for a unit of Novartis AG.
The Novartis unit, Sandoz, and partner Momenta Pharmaceuticals Inc. have been in a tug of war for years with a California-based company, Amphastar Pharmaceuticals Inc., to win FDA approval for generic versions of Lovenox.
Amphastar has accused the FDA and its drug-division leaders of favoritism in the past year, noting that Momenta worked closely with the FDA on safety issues and investigations in recent years. Momenta has said its relationship with the FDA is appropriate.
Sanofi has fought to protect Lovenox from generic competition, saying that the drug is too complex to be completely copied safely. Researchers with ties to Sanofi recently filed citizens' petitions to the FDA asking the agency not to approve any company's enoxaparin.
