Pfizer recalls lot of ThermaCare HeatWraps Menstrual
NEW YORK Pfizer’s over-the-counter division recalled one lot of a ThermaCare product over the possibility of leaks.
Pfizer Consumer Healthcare announced Friday the voluntary recall of lot number E06931 of its ThermaCare HeatWraps Menstrual product and notified the Food and Drug Administration.
The company said possible leaks in the wraps could cause skin injury, such as irritation and burning.
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.”