Tag: USFDA

Natco Pharma’s marketing partner gets USFDA nod for anti-cancer drug – ET HealthWorld

Natco Pharma on Monday said its marketing partner Breckenridge Pharmaceutical Inc has received approval from the US health regulator for anti-cancer drug Carfilzomib Vials. “Breckenridge Pharmaceutical Inc. (BPI), has received approval for its abbreviated new drug application (ANDA) for Carfilzomib Vials ANDA (generic for Kyprolis), from the US Food and Drug Administration (USFDA),” Natco Pharma […]

Read More

Lupin gets warning letter from USFDA for Somerset facility – ET HealthWorld

Drug firm Lupin on Sunday said it has received a warning letter from the US health regulator for its Somerset facility in the US. The United States Food and Drug Administration (USFDA) had inspected the company’s Somerset, New Jersey, facility from September 10, 2020, to November 5, 2020, Lupin said in a regulatory filing. “The […]

Read More

No plans to get into vaccine production as it requires separate manufacturing infra: Sun Pharma – ET HealthWorld

Sun Pharma has no immediate plans to enter into vaccine production as getting into the vertical would require an altogether different manufacturing set-up, as per a top company official. The Mumbai-based company, which is strong in various generic therapeutic segments, is eyeing biosimilars to fuel its future growth. “I think our preliminary assessment indicates that […]

Read More

FDA denies emergency use nod for Covaxin in US – ET HealthWorld

New Delhi: The US Food and Drug administration has denied approval for emergency use of Bharat Biotech’s Covaxin, and has asked for additional data, biopharmaceutical Ocugen, the US partner of the Indian vaccine maker has said. FDA recommended that Ocugen “pursue a Biologics Licence Application (BLA) submission instead of an EUA application” and “requested additional […]

Read More

FDA rejects Ocugen’s emergency use authorization for Bharat Biotech’s Covaxin in the US, seeks nod from Health Canada

Biopharmaceutical company, Ocugen, has announced that recommendation from the U.S. Food and Drug Administration (FDA), the company will pursue submission of a biologics license application (BLA) for its COVID-19 vaccine candidate, COVAXIN. The Company will no longer pursue an Emergency Use Authorization (EUA) for COVAXIN. COVAXIN, India’s COVID-19 vaccine by Bharat Biotech, is developed in […]

Read More

FDA earlier told that no new EUA will be approved for covid vaccines: Bharat Biotech – ET HealthWorld

Hyderabad-based Bharat Biotech today said that the USFDA had earlier communicated that no new Emergency Use Authorisation (EUA) will be approved for covid vaccines, a day after its US partner Ocugen hit a major bump after FDA rejected EUA for Covaxin. The Pennsylvania-based eye disease company had to change its application from an Emergency Use […]

Read More

Ocugen to file for full US approval of Covid-19 shot Covaxin instead of EUA – ET HealthWorld

Ocugen Inc said on Thursday it would no longer pursue an emergency use authorization for its Covid-19 vaccine candidate, Covaxin, and would instead aim to file for a full U.S. approval of the shot. Ocugen said the decision was based on a recommendation from the U.S. Food and Drug Administration (FDA), which also requested more […]

Read More

Lupin gets USFDA nod to market generic HIV drug – ET HealthWorld

Drug firm Lupin on Monday said it has received a nod from the US health regulator to market generic Emtricitabine and Tenofovir Disoproxil Fumarate tablets used for the treatment of human immunodeficiency virus (HIV) -1 infection in the American market. The company has received approval from the United States Food and Drug Administration (USFDA) to […]

Read More

Dr Reddy’s recalls 2,980 bottles of cholesterol lowering drug in US – ET HealthWorld

New Delhi: Drug major Dr Reddy’s Laboratories is recalling 2,980 bottles of Atorvastatin Calcium tablets in the US due to quality issues. Atorvastatin is indicated to lower cholesterol in the blood for adults and children over ten years of age. The drug is also prescribed to lower the risk of heart attack and stroke in […]

Read More

US sales of Gujarat pharma firms slump – ET HealthWorld

Ahmedabad: Even as overall pharma exports showed a robust growth in 2020-21, Gujarat-based top pharma companies’ revenues from the US market declined in the fourth quarter ended March 31. The US market sales were largely impacted due to the price erosion in old products due to increased competition. The lower US sales, however, were offset […]

Read More