Page 26 - Usfda
Zydus Cadila gets USFDA nod to market generic antihistamine tablets
The drug will be manufactured at the group's manufacturing facility in Ahmedabad
 "Zydus Cadila gets USFDA nod to market generic antihistamine tablets")
USFDA removes partial lifting of import on API facility at Ratlam: Ipca Lab
USFDA had partially lifted import alert imposed on the company's API plant at Ratlam and formulations units at Pithampur in the same state and Piparia in Silvassa
Shot of Hope: Equal access a hurdle after race to coronavirus vaccine
The second of a two-part series examines challenges linked to IPR and monopoly once Covid-19 vaccine is created
 "Shot of Hope: Equal access a hurdle after race to coronavirus vaccine")
Alembic Pharma gets tentative USFDA nod for generic Rivaroxaban tablets
The tablet is the generic of Janssen Pharmaceuticals Inc's reference listed drug product Xarelto
Covid-19 crisis: Cipla launches generic remdesivir under brand name Cipremi
The USFDA had issued an Emergency Use Authorization (EUA) to Gilead Sciences Inc for emergency use of remdesivir for the treatment of Covid-19 patients
 "Covid-19 crisis: Cipla launches generic remdesivir under brand name Cipremi")
Unichem, Lupin recall high blood pressure drugs from US over quality issues
The specified batch, which is being recalled, has been manufactured at Unichem's Goa-based facility
 "Unichem, Lupin recall high blood pressure drugs from US over quality issues")
Piramal Pharma Solutions to acquire G&W Laboratories' drug facility in US
The site has received certifications from the Food and Drug Administration and European Medicines Agency
 "Piramal Pharma Solutions to acquire G&W Laboratories' drug facility in US")
Cadila Healthcare's Q4 PBT falls 14% to Rs 522 cr, total income rises 0.66%
Cadila has also been working on a DNA vaccine to fight Covid-19, which is currently in the animal testing stage
 "Cadila Healthcare's Q4 PBT falls 14% to Rs 522 cr, total income rises 0.66%")
Alembic Pharma gets USFDA nod for generic Adapalene gel for acne treatment
The product was indicated for the topical treatment of acne vulgaris in patients 12 years of age and older, Alembic Pharma said
 "Alembic Pharma gets USFDA nod for generic Adapalene gel for acne treatment")
Glenmark Pharma gets USFDA nod for drug to treat multiple sclerosis
The capsules are used in the treatment of adult patients with relapsing forms of multiple sclerosis
 "Glenmark Pharma gets USFDA nod for drug to treat multiple sclerosis")
Sun Pharma, Hikma ink pact for plaque psoriasis drug for MENA region
One of the company's wholly-owned subsidiaries and Hikma Pharmaceuticals have entered into the agreement for Ilumya, Sun Pharma said in a filing to BSE
 "Sun Pharma, Hikma ink pact for plaque psoriasis drug for MENA region")
Dr Reddy's inks pact with Gilead to manufacture, market Remdesivir in India
Dr Reddy's would need to scale up manufacturing and obtain regulatory approval for marketing of this drug in respective countries, the company said
 "Dr Reddy's inks pact with Gilead to manufacture, market Remdesivir in India")
Gilead finds fourth partner for manufacture of Remdesivir in Zydus Cadila
Indian drug maker to get know-how from Gilead Sciences Inc, to manufacture the API for Remdesivir, make the finished product and market it in 127 countries, including India
 "Gilead finds fourth partner for manufacture of Remdesivir in Zydus Cadila")
Biocon gets a shot in the arm with FDA approval for insulin glargine
The drug will be major contributor in the firm's bid to reach $1 billion revenue target by FY22, says biologics CEO Hamacher
 "Biocon gets a shot in the arm with FDA approval for insulin glargine")
US FDA grants orphan drug status to mexiletine hydrochloride: Lupin
The Mumbai-based company's drug NaMuscula (mexiletine hydrochloride) is the first and only licensed product to treat myotonia in adults with non-dystrophic myotonic (NDM) disorders
 "US FDA grants orphan drug status to mexiletine hydrochloride: Lupin")
Zydus Cadila gets USFDA nod for generic antiviral drug, Atazanavir capsules
Atazanavir, an antiretroviral drug, is used to treat Human Immunodeficiency Virus (HIV-1) infection incombination with other antiretroviral drugs
 "Zydus Cadila gets USFDA nod for generic antiviral drug, Atazanavir capsules")
Covid-19 crisis: Indian drug companies yet to get nod to market remdesivir
The USFDA granted remdesivir an emergency use authorization for the treatment of hospitalized patients with severe Covid-19
 "Covid-19 crisis: Indian drug companies yet to get nod to market remdesivir")
Gilead's remdesivir shows modest improvement in moderate Covid-19 patients
At day 11, around 76% of the patients in the 5-day treatment group showed improvement in clinical status versus 66% for standard care alone, Gilead said
 "Gilead's remdesivir shows modest improvement in moderate Covid-19 patients")
Trump says he has been taking Hydroxychloroquine despite FDA warning
The President, according to The Hill report, said he consulted with the White House doctor about taking the drug, but it was not explicitly recommended for him
 "Trump says he has been taking Hydroxychloroquine despite FDA warning")
Huge scope for Indian pharma as FDA eases drug scrutiny over shortage in US
Injectibles account for 60% of crunch; most plants under American regulator's lens the past two months have now received positive outcomes
 "Huge scope for Indian pharma as FDA eases drug scrutiny over shortage in US")
