Problems that began three years ago with K-V Pharmaceuticals hiding manufacturing lapses from the FDA have escalated into a Chapter 11 bankruptcy filing by the maker of Makena, a drug to prevent premature birth.
Accusing regulators of failing to protect its birth drug, K-V Pharmaceutical has filed for bankruptcy with debts listed at $728.3 million and assets valued at $236.6 million, Reuters reported over the weekend.
Short on alternatives to boost sales of its pre-term birth drug Makena and to stay afloat, K-V Pharmaceutical has mounted a lawsuit against the FDA for failing to stop pharmacies from preparing their own versions of the drug, Reuters reported.
The battle over KV Pharmaceuticals' pricey preterm-labor drug, Makena, with pharmacy compounders who can make it for next to nothing has hit a new phase.
Problems just never seem to end for KV Pharmaceutical ($KV.A), the St. Louis drugmaker that for several years now has been trying to regain its footing after the FDA smacked it with a consent decree over its self-made manufacturing debacle.
Regulators at the FDA issued a brutal review for Columbia Laboratories' ($CBRX) application for its progesterone vaginal gel to prevent preterm delivery, saying the developer didn't provide the data
Things gone wrong at the top is the subject of a 10-company roundup of 2011's spectacular executive departures. The story ran in InPharm, but the list includes shenanigans from the banking, retail
KV Pharmaceuticals ($KV.A) has "substantial doubt" about its ability to "continue as a going concern," according to a financial statement filed last week. In the Form 10-Q, the troubled drugmaker
Pharmacy services provider PharMerica Corp. is questioning claims made recently by KV Pharmaceutical ($KV.A) that the latter's FDA-approved premature-birth prevention drug Makena provides greater
Tuesday was a good day for beleaguered KV Pharma ($KV.A), known recently for its he-said/she-said lawsuits with a former CEO and its exorbitant price setting of preterm-birth preventer Makena after