K-V sues FDA over Makena in fight for survival | Reuters:
The FDA normally issues warning letters to distributors of unapproved drugs, or may seize their products.
The FDA recently launched a drive to remove all unapproved drugs from the market due to safety issues, and encouraged companies to apply for formal clearance, but has not taken a hard line against the pre-term birth medications.
Patients and insurers preferred the pharmacy compounds, which cost $10 to $20 per injection versus the $1,500 K-V initially sought to charge for Makena after it was approved in February 2011.
K-V reportedly tried to stop pharmacies from compounding the drug by sending them letters saying they were violating the law and threatening to sue them."
'via Blog this'
The case is K-V Pharmaceutical Company v. FDA, U.S. District Court, District of Columbia, No. 12-01105.
Learn more about the case at: Complaint Filed in K-V v. FDA, case number 12-01105
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