FDA rejects Momenta Pharmaceuticals' partner's drug
Biotechnology company Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) disclosed this morning that its collaboration partner, Sandoz Inc., received a letter from the U.S. Food and Drug Administration stating that Sandoz' abbreviated new drug application for Enoxaparin Sodium Injection is “not approvable.”
The FDA said the application was not approvable because it did not adequately address the potential for immunogenicity of the drug product. Momenta said the FDA recommended that it, along with Sandoz, meet with the Office of Generic Drugs to determine additional information required to adequately address the concern.
Momenta said it’s working with Sandoz to identify the additional information necessary to obtain approval from the FDA.
Shares of Momenta Pharmaceuticals (MNTA) plummeted 45.52%, or $6.09, to $7.29 ahead of the opening bell. Shares of Momenta Pharmaceuticals have been trading in the range of $9.05 to $21.98 for the past 52 weeks.
