Amgen recalls certain lots of Epogen, Procrit
THOUSAND OAKS, Calif. Several lots of two drugs used to treat anemia are being recalled due to possible contamination.
Amgen said Friday that it was voluntarily recalling certain lots of Epogen and Procrit (epoetin alfa) from distributors, wholesalers, healthcare providers and pharmacies as a precaution due to the possible presence of extremely thin and barely visible glass flakes known as lamellae that result from an interaction between the drugs and the glass vials used to store them.
The drugs are used to treat anemia resulting from chemotherapy, kidney failure and HIV therapy.
NBTY shareholders OK adopting merger agreement
RONKONKOMA, N.Y. NBTY on Wednesday announced that its stockholders have approved the proposal to adopt the merger agreement providing for NBTY’s acquisition by an affiliate of The Carlyle Group.
The affirmative vote of the holders of a majority of the outstanding shares of common stock of NBTY was required to approve the proposal to adopt the merger agreement. According to the final tally of shares voted, approximately 50.5 million shares of common stock of NBTY voted for the approval of the proposal to adopt the merger agreement, representing approximately 79.6% of the outstanding shares of common stock of NBTY as of the close of business on Aug. 23, the record date for this vote.
Following the approval of the proposal to adopt the merger agreement by NBTY’s stockholders, all conditions to the closing of the merger set forth in the merger agreement have been satisfied (other than those conditions to be satisfied by action taken by the parties at the closing). Under the merger agreement, the affiliate of Carlyle is obligated to consummate the merger upon completion of the 20-day marketing period for the debt financing, which will commence on Sept. 23, but it is NBTY’s expectation that the merger could be completed as soon as the beginning of October.
Bionovo receives CMC approval for Menerba
EMERYVILLE, Calif. The Food and Drug Administration has approved a manufacturing plan for a drug to treat hot flashes in menopausal women.
Bionovo said Thursday that the FDA had accepted its chemistry, manufacturing and controls plan for the drug Menerba. The decisions and agreements are considered binding on the company and the FDA.
“This CMC approval represents a revolutionary set of ‘firsts,’” Bionovo chairman and CEO Isaac Cohen said. “This is the first time that the FDA’s botanical drug development CMC guidance has been applied to an oral drug in a major indication.”