Gets US FDA nod for migraine drug
Panacea Biotec has inked a pact with UNICEF for the supply of Pentavalent Vaccine (Easyfive-TT) in the current year. The company has also received a notification from Pan American Health Organisation (PAHO) for the purchase of Easyfive-TT vaccine in the event the agency should have any requirements through December, 31, 2019.
“Total value of this expected business from UN Agencies is worth $20.475 million equivalent to around Rs 140 crore based on current exchange rate,” Panacea Biotec said in a statement.
Besides, the company has received approval from the US health regulator to market a generic version of Merck & Co’s Maxalt-MLT tablets, used in treating migraine, in the American market.
Commenting on the developments, Rajesh Jain, Joint MD, Panacea Biotec, said that another product approval by US FDA and UN Agencies business would help the company to grow in a sustainable manner in mid to long term.
The company has received approval from the US Food and Drug Administration (US FDA) to market its generic product to treat migraine in strengths of 5 and 10 mg, Panacea Biotec said in a statement.
Panacea’s product is equivalent to Merck & Co’s Maxalt-MLT tablets. The drug has annual sales of around $60 million in the US market.
“The company plans to launch the product within first quarter of 2017 through its distribution partner in the US,” Panacea said.
The company recently got approval for its anti-cancer formulation facility from US FDA in November 2016, it added.