Aurobindo Pharma has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Esmolol hydrochloride injection, 100mg/10mL (10mg/mL).
Esmolol hydrochloride injection, 100mg/10mL (10mg/mL) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Brevibloc injection, 10mg/mL of Baxter Healthcare Corporation.
Esmolol Hydrochloride Injection is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period.
Aurobindo now has 13 ANDAs (represented by 10 product classes) approved out of Unit IV formulation facility in Hyderabad, India for manufacturing general injectable products and will be marketed and sold by Aurobindo’s wholly owned subsidiary AuroMedics Pharma LLC.
02:20 pm Jaitley on P-Note woes: To soothe nerves of jittery foreign investors after an SIT on black money suggested stricter norms for P-notes, the Government today said it will not take any “knee-jerk” reaction that will adversely impact country’s investment climate. With markets tanking on the recommendations of the Supreme Court-appointed SIT on black money last week that Sebi should tighten norms related to Participatory notes (P-notes) investments into India, Finance Minister Arun Jaitley said the government will study the suggestions before taking a stand.
“It is too early to say what view the government would take. But the it will certainly not take any such action in a knee-jerk reaction, particularly one which has any adverse impact on investment environment,” he told reporters in his Parliament House Office. “No such step would be taken which could adversely impact investment sentiment in the country,” Jaitley said. Jaitley said the suggestions and recommendations made by the SIT on black money will come up to the government and “the government will apply its mind in due course keeping in mind the investment environment of the country as also the objective behind the SIT recommendations and then take a final view on the matter.”
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