Barr Pharmaceuticals has resubmitted an application to US regulators to make available its morning-after pill, Plan B, without a prescription.
The company's original application sought approval to sell Plan B over-the-counter to women of all ages. This was later changed to those aged 16 and above, but the Food and Drug Administration said it would only take another look at Barr's application if non-prescription sales were restricted to adult women.
The FDA has reportedly confirmed receipt of Barr’s revised application, but has not disclosed its contents.
Meanwhile, the group has formally published its tender offer for the purchase of 100% of the shares of Croatian drugmaker Pliva, thereby kick-starting the tender process, which is expected to take around 30 days.
Under the terms of Barr’s offer, Pliva shareholders will get around $131 per share in cash and those registered at the Central Depository Agency by August 22 will receive an extra dividend of $2 per share, the group said.
The offer, which is dependent on Barr obtaining a 50% or more stake in the Pliva, beat that of rival suitor Actavis, which has already built a 20% stake in Pliva through stock purchases and option agreements.