Page 29 - Usfda

Test that can detect coronavirus in 5 minutes; courtesy Abbott Labs

Abbott to supply 50,000 tests a day starting April 1

Top headlines: FM's relief package for poor, Cipla gets USFDA nod, and more

Business Standard brings to you the top headlines of the day

Pharma major Cipla gets USFDA nod for generic oral acid reflux drug

According to IQVIA, Nexium and its generic equivalents had US sales of around $70 million for the 12 months ended November 2019

Glenmark gets tentative nod from USFDA for generic type-2 diabetes tablets

The product is a generic version of AstraZeneca AB's Farxiga tablets

Ipca and Cadila Healthcare gear up to make drug for coronavirus

Ipca is the biggest producer of the drug. Cadila Healthcare, based in Ahmedabad, too is a major player

Biocon receives EIR from USFDA for good manufacturing practice inspection

"We remain committed to global standards of quality and compliance," company spokesperson said

US approves anti-malarial drug to treat COVID-19, says Donald Trump

But the FDA Commissioner Stephen Hahn later indicated that, while the drug has not yet been formally approved, access to it was being expanded so that authorities could gather more data

Dr Reddy's launches generic Ziprasidone Mesylate for injection in US

It's the therapeutic generic equivalent of Geodon Injections

Alkem Laboratories gets EIR from USFDA for manufacturing facility at Baddi

The USFDA has now issued an EIR for the manufacturing facility, it added.

Biocon, Mylan win patent case for insulin device against Sanofi in US

Development takes Biocon a step closer to commercialise its glargine biosimilar Semglee in America

Biocon partner's Cancer drug licence application gets USFDA approval

The application sought approval of Mylan's drug for treatment of patients with metastatic colorectal cancer with fluorouracil-based chemotherapy

USFDA accepts Biocon-Mylan's Avastin biosimilar application for review

The application seeks approval of biosimilar bevacizumab for treatment of patients with metastatic colorectal cancer in addition to other ailments

USFDA accepts proposed biosimilar application by Mylan, Biocon for review

The application seeks approval of Bevacizumab for the first-line and second-line treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy

Alembic gets USFDA approval for generic doxycycline hyclate tablets

Doxycycline hyclate tablets are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients

Strides Pharma Science gets USFDA nod for generic anti-bacterial capsules

The product is a generic version of Achromycin V Capsules, 250 mg and 500 mg, of Avet Pharmaceuticals (previously Heritage Pharmaceuticals)

USFDA warnings: Concerns remain even as India fares better than US

According to the USFDA, India accounted for nearly 18 per cent of the active pharmaceutical ingredients (APIs) sourced by the US, while China accounted for 13 per cent

Dr Reddy's gets 1 observation from USFDA after inspecting Hyderabad plant

Earlier, the drug major had said that the US health regulator has issued a Form 483 with two observations after inspecting the facility but later it was issued revised Form 483 with one observation

India scores better than US in regulatory action by USFDA in 2019

From FY15 to FY19, Indian manufacturers received fewer warning letters than Chinese counterparts

Biocon gets two observations from USFDA for Bengaluru-based API plant

Biocon shares on Thurday ended 0.17 per cent up at Rs 299.20 apiece on the BSE.

USFDA issues warning letter to Cipla for Goa manufacturing facility

The company further said that it remains committed to maintain highest standards of compliance and will work closely with the agency to comprehensively address all the observations