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FDA

Govt appoints Deepak Gaikwad as State Licensing Authority FDA Karnataka

Karnataka government has appointed Deepak Gaikwad, Deputy Drugs Controller, Regional Office, Belgaum, as the State Licensing Authority. This is in adherence to...
USFDA

USFDA gives final nod to Alembic for Formoterol Fumarate inhalation solution

Alembic Pharmaceuticals today announced that it has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New...
USFDA

USFDA grants accelerated approval for Vosoritide for injection

San Rafael: BioMarin Pharmaceutical Inc. has recently announced that the U.S. Food and Drug Administration (USFDA) has granted accelerated approval to VOXZOGO (vosoritide)...
FDA

Kerala SDC urges IPEC to follow USFDA guidelines to ensure quality of excipients used...

To ensure the proper performance of an excipient in a drug formulation, the Kerala state drug control department has called on the...
USFDA

Zydus Cadila gets USFDA nod to market generic Cancer drug in US

Drug firm Zydus Cadila on Saturday said it has received approval from the US health regulator to market Decitabine injection, used to treat certain types of...
Medicine Tablets

Retired FDA officials are promoting Generic Drugs in innovative ways

Retired drug regulatory officers in West Bengal along with socially committed NGOs and IPA, are adopting new strategies to promote the use...
Cosmetics medicine

Aleor Derma gets USFDA nod for Antibacterial Cream: Alembic

Mumbai: Alembic Pharmaceuticals Limited announced that its joint venture Aleor Dermaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA)...
USFDA

USFDA promises quick review of Pfizer booster vaccine for all adults

The U.S. Food and Drug Administration (USFDA) said, it would review Pfizer Inc's request to authorize booster doses of the C-19 vaccine in all adults "as...
FDA

Special search operation at Medical Stores: FDA Punjab

Ferozepur: Food and Drugs Administration (FDA) Punjab, along with the police, conducted a special search operation at various places.
USFDA

USFDA gives nod to Zydus Pharma for Eluxadoline Tablets

Zydus Cadila said today that its US subsidiary, Zydus Pharmaceuticals (USA) Inc., has obtained provisional permission from the US Food and Drug Administration (USFDA) to comercialise Eluxadoline Tablets in 75 mg and 100 mg dosages (US RLD: VIBERZI Tablets). Irritable bowel syndrome with diarrhoea or IBS-D, is treated with Eluxadoline Tablets in adults.
Medicine Capsule

Indian Pharma Cos perceives USFDA’s rules on these listed drugs

Indian pharma sees considerable relevance to the USFDA guidance on reporting amount of listed drugs and biological products based on technical conformance.
USFDA

USFDA gives final nod to Zydus Cadila for Glycopyrrolate Injection

Ahmedabad, India: Global pharmaceutical company Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market its glycopyrrolate injection,...

Temporary Tattoos, Mehndi, and Black Henna are safe? Explained by USFDA

Temporary Tattoos Temporary tattoos can be applied to any region of the body, including the face and eyes,...
USFDA

USFDA approves Drug to treat Hyperactivity disorder

The USFDA has approved amphetamine (Dyanavel XR, Tris Pharma) extended-release once daily tablet, for the treatment of individuals 6 years of age...
USFDA

USFDA’s nod for Kerala’s local herb Manathakkali for Liver Cancer Treatment

USFDA's nod for Kerala’s local herb Manathakkali THIRUVANANTHAPURAM: ‘Manathakkali’ (Black nightshade or Solanum nigrum), a berry-bearing shrub found...
USFDA

USFDA nod for Cortrophin Gel to treat Autoimmune Disorders

ANI Pharmaceuticals, Inc. announced that the US Food and Drug Administration (USFDA) has approved the company’s supplemental New Drug Application (sNDA) for...
USFDA

Allergan gets USFDA nod for eye drop to treat blurry vision

Allergan, an AbbVie company, announced the US Food and Drug Administration (USFDA) approval of Vuity (pilocarpine HCl ophthalmic solution) 1.25% for the...
FDA

FDA cancels licenses of 2 Blood Cantres, suspends 12 firms

PUNE The Maharashtra Food and Drugs Administration (FDA) has cancelled the licenses of two Blood Centres (Blood Banks), suspended 12 firms and...
USFDA

Novartis gets USFDA approval for drug to treat Chronic Leukemia

Novartis announced that the US Food and Drug Administration (USFDA) approved Scemblix (asciminib) for the treatment of chronic myeloid leukemia (CML) in...
USFDA

USFDA clears Pfizer’s C-19 Vaccine for children aged 5 to 11

Pfizer Inc. and BioNTech SE’s C-19 vaccine was cleared by US regulators for children ages 5 to 11, a long-awaited pandemic milestone...
Medicines

Indian Pharma considers USFDA guidance on real World data

Indian pharma considers USFDA guidance on real-world data: assessing electronic health records (EHR) and medical claims data will support regulatory decision making...
FDA Haryana

FDA Haryana: Webinar organized for the Chemists of Haryana

A webinar was organized for the chemists of Ambala and Panchkula zones, Haryana by the Price Monitoring and Resource Unit (PMRU) working...
USFDA

USFDA approves Naloxone HCL injection to counteract opioid overdoses

USFDA has approved ZIMHI (naloxone hydrochloride) injection as an additional option to treat opioid overdose. ZIMHI is administered using a...
USFDA

USFDA gives approval for Eye Injection to teat vision loss

(Reuters) - Bausch Health Companies Inc and Clearside Biomedical Inc said they received approval from the U.S. health regulator (USFDA) for their...

Latest posts

High Court restrains publishing Ads in a dispute on Chyawanprash

The Calcutta High Court has issued an interim injunction restraining Shree Baidyanath Ayurved Bhawan Pvt Ltd from issuing certain print and video...

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