You Searched For "USFDA approvals" and got 20 results
Sort By:
1 min read
Glenmark gets USFDA nod for generic drug used to treat mental disorder
Glenmark Pharmaceuticals Ltd on Tuesday said it has received final approval from the US health regu…
PTI
1 min read
Granules India gets USFDA nod for generic drug used for short-term treatment of heartburn
Granules India Ltd on Thursday said it has received approval from the US health regulator for its g…
PTI
1 min read
Glenmark gets USFDA nod to market generic medication
The company's product is the generic version of GlaxoSmithKline's Compazine tablets, it added. …
PTI
1 min read
Alembic Pharma gets USFDA nod for generic cancer drug
Fluorouracil injection is indicated for the treatment of patients with adenocarcinoma of the colon …
PTI
3 mins read
USFDA has set a new record in generic drug approvals this year-- but Indian drug makers have a lot to gain and little to lose
The American drug regulator approved 953 new generic drugs between October 2018 and June 2019. T…
2 mins read
COVID-19: India's drug regulator may soon give restricted emergency use authorisation to American vaccine Moderna
According to the sources, an approval is likely anytime as the CDSCO is in favour of granting…
PTI
1 min read
Unichem Lab shares rise over 12 pc after USFDA approval for hypertension drug
New Delhi, Nov 25 () Unichem Laboratories' shares on Monday surged over 12 per cent after the compa…
PTI
1 min read
USFDA rejects SPARC's cancer drug application
"The company has received a Complete Response Letter (CRL) from the United States Food & Drug …
PTI
3 mins read
Biocon shares are depressed itself but Syngene can offer a shot of hope
The Bengaluru-based biopharmaceutical company Biocon Limited share price fell over 3%. Investors …
1 min read
Indoco gets USFDA nod for Febuxostat tablets
New Delhi, Dec 31 () Indoco Remedies on Tuesday said it has got final approval from the US health r…
PTI
2 mins read
USFDA issues warning letter to Cipla for Goa plant
The significant violations included company's failure "to clean, maintain, and, as appropriate for…
PTI
1 min read
Alembic gets USFDA nod for doxycycline hyclate tablets
Doxycycline hyclate tablets are indicated for use as an adjunct to scaling and root planing to pro…
PTI
1 min read
Strides gets USFDA nod for anti-allergic drug
New Delhi, Jan 16 () Strides Pharma Science on Thursday said it has received approval from the US h…
PTI
1 min read
Glenmark gets USFDA's final nod for Deferasirox tablets
New Delhi, Jan 7 () Glenmark Pharmaceuticals on Tuesday said it has got final approval from the US …
PTI
1 min read
Biocon gets EIR from USFDA for manufacturing facility in Bengaluru
"Biocon has received the EIR from the US Food and Drug Administration (FDA) for the post-approval …
PTI
1 min read
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 pati…
PTI
1 min read
Biocon gets 3 USFDA observations for insulin facility in Malaysia
As per the USFDA, Form 483 is issued to firm management at the conclusion of an inspection when in…
PTI
1 min read
Zydus Cadila gets USFDA nod to market Mesalamine suppositories
Mesalamine Suppositories is an aminosalicylate anti-inflammatory drug and is believed to work by b…
PTI
1 min read
Granules Pharmaceuticals, Inc gets USFDA nod for Colchicine tablets
"The US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (…
PTI
1 min read
Zydus Cadila gets USFDA nod to market ointment for treating skin conditions
The company has received final approval from the United States Food and Drug Administration (USFDA…