Page 6 - Usfda

FDA may authorise Pfizer's Covid vax for kids under 5 in Feb: Fauci

The US Food and Drug Administration (FDA) is likely to approve Pfizer's Covid vaccine for children under 5 years of age in February, White House chief medical advisor Anthony Fauci has said.

Zydus gets final USFDA nod to market generic version of Vigabatrin tablets

Cadila Healthcare said group firm Zydus has received final approval from the US health regulator to market its generic version of Vigabatrin tablets

Aurobindo Pharma gets warning letter from USFDA for API facility

Aurobindo Pharma on Friday said it has received a warning letter from the US health regulator for its Hyderabad-based Unit I, an API manufacturing facility.

Glenmark gets USFDA nod for nasal spray to treat seasonal allergic rhinitis

Glenmark Pharma on Friday said its subsidiary has received approval from the US health regulator to market Ryaltris, a nasal spray for the treatment of seasonal allergic rhinitis.

Alembic Pharmaceuticals gets USFDA nod to market generic product

Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market generic Dronedarone tablets, which is used to reduce risk of hospitalisation for atrial fibrillation, in the American market. The company has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for its medication in strength of 400 mg, the drug maker said in a statement. The tentatively approved ANDA is therapeutically equivalent to Sanofi-Aventis' Reference Listed Drug (RLD) product Multaq Tablets, 400 mg. Dronedarone is indicated to reduce the risk of hospitalisation for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation. Cumulatively, the company has so far received 158 ANDA approvals from USFDA.

USFDA rejects Biocon, Viatris application for Insulin Aspart

The company will respond to the CRL to satisfy the FDA's requests

Alembic Pharma gets tentative USFDA approval for depressive disorder drug

Alembic Pharmaceuticals Ltd on Friday said it has received tentative approval from the US health regulator for its generic Vortioxetine tablets indicated for the treatment of the major depressive disorder. The tentative approval granted by the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Vortioxetine tablets of strengths in 5 mg, 10 mg, 15 mg and 20 mg, the company said in a statement. These are therapeutically equivalent to the reference listed drug product (RLD) Trintellix tablets 5 mg, 10 mg, 15 mg, and 20 mg of Takeda Pharmaceuticals, USA, Inc, it added. Citing IQVIA data, the company said these Vortioxetine tablets have an estimated market size of USD 1,249 million for twelve months ending September 2021. Alembic, however, said it is currently in litigation with H Lundbeck in the Court of appeals for the Federal Circuit and the launch of the product will depend on litigation outcome. "It is possible that our ANDA may not be ...

Alembic gets USFDA nod for generic drug to treat bacterial infections

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Doxycycline Hyclate delayed-release tablets

Granules India gets USFDA nod for its generic Amphetamine mixed salts

This is for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy

Rapid antigen tests have reduced sensitivity against Omicron: US FDA

Although rapid antigen tests can detect the Omicron variant it may be less sensitive, according to the US Food and Drug Administration (FDA)

Lupin receives tentative USFDA nod for generic Azilsartan Medoxomil tablets

The tentative approval by the US Food and Drug Administration (USFDA) for the abbreviated new drug application (ANDA) Azilsartan Medoxomil tablets is for strengths of 40 mg and 80 mg

US nod for Covid-19 drug molnupiravir raises hope for Indian approval

Oral medication targets ribonucleic acid polymerase, a part of the virus that has not changed much after mutations in the Omicron variant.

Cipla receives USFDA nod to market Lanreotide injection in US market

Drug major Cipla on Sunday said it has received approval from the US health regulator to market the Lanreotide injection, used for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumors, in the American market.

'USFDA study shows Evusheld retains neutralising activity against Omicron'

The study was done independently by investigators at the US Food and Drug Administration (USFDA), Center for Biologics Evaluation and Research.

US business rebound key to further upsides in Lupin, VAI may offer relief

Clearance for Goa unit is positive; near-term triggers are new launches and market share gains

USFDA inspection of co's US plant completed successfully: Torrent Pharma

Torrent Pharmaceuticals Ltd on Thursday said its manufacturing facility at Levittown, Pennsylvania in the US has successfully completed inspection by the USFDA. The plant was inspected by USFDA (United States Food and Drug Administration) between December 6 and December 15, 2021. At the end of the inspection, no 'Form 483' was issued, the company said in a regulatory filing. As per the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. "It is a positive development for the company and is a reflection of our commitment to consistency in quality and compliance with regulatory standards," Torrent Pharmaceuticals said. According to information available on the company's website, the Levittown manufacturing facility is a part of Torrent Pharma's acquisition of Bio-Pharm, Inc (BPI) in 2018. It has ...

Zydus gets orphan drug designation from USFDA for antimalarial compound

The orphan drug designation provides eligibility for certain development incentives

US FDA clears Lupin's Goa plant, paves way for new product approvals

Goa plant has an annual capacity of 6 billion units of tablets, capsules or oral suspension drugs. It accounts for 18-20% of firm's US revenue

Lupin receives inspection report from USFDA for Goa manufacturing facility

Homegrown pharma major Lupin Ltd on Tuesday said it has received the Establishment Inspection Report (EIR) from USFDA for its Goa manufacturing facility after an inspection in Sept 2021

Zydus Cadila gets USFDA approval to market generic schizophrenia drug

Cariprazine is an atypical antipsychotic medication used for the treatment of schizophrenia and acute treatment of manic or mixed episodes associated with bipolar disorder.