Page 2 - Us Fda

US FDA issues 11 observations each for two sites in Bengaluru: Biocon

Biocon Ltd on Wednesday said the US health regulator has issued Form 483s with 11 observations each for two sites in Bengaluru and six observations for a plant in Malaysia, following inspection of seven manufacturing facilities of its arm Biocon Biologics. As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The USFDA conducted three on-site inspections of Biocon Biologics' seven manufacturing facilities spanning two sites in Bengaluru, India and one at Johor, Malaysia, Biocon said in a regulatory filing. The inspections started with the Bengaluru site on August 11, 2022 and concluded with the Malaysia site on August 30, 2022, it added. "At the conclusion of these inspections, the agency has issued Form 483s with 11 observations each for the two sites in Bengaluru and six .

Zydus gets USFDA nod for generic version of Venlafaxine, Pregabalin

Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to market its generic version of venlafaxine extended-release tablets used to treat depression. The company also said the US Food and Drug Administration (USFDA) has granted final approval for pregabalin extended-release tablets used to treat pain caused by nerve damage due to diabetes or shingles (herpes zoster) infection. The approval granted by the USFDA for venlafaxine extended-release tablets is for strengths of 37.5 mg, 75 mg, 150 mg and 225 mg, Zydus Lifesciences said in a regulatory filing. Venlafaxine is used to treat depression, anxiety, panic attacks and social anxiety disorder. It had annual sales of USD 46 million in the US, the company said citing IQVIA MAT July 2022. Further, Zydus Lifesciences said the final approval granted by the USFDA to market pregabalin extended-release tablets is for strengths of 82.5 mg, 165 mg and 330 mg. The drug had annual sales of USD 3 ..

Explained: What is the controversy around J&J's talc-based baby powder?

Johnson and Johnson (J&J) has been facing several thousand lawsuits from women who claim that they developed ovarian cancer after using the product

Lupin gets USFDA approval to market generic cancer treatment drug

Lupin on Monday said it has received a tentative approval from the US health regulator to market Dasatinib tablets, used to treat certain types of cancer, in America. The company in partnership with Pharmascience Inc. has received approval from the US Food and Drug Administration (FDA) for Dasatinib tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, it said in a statement. The Mumbai-based drug maker's product is a generic version of Bristol-Myers Squibb Company's Sprycel tablets. As per IQVIA MAT data, Dasatinib tablets had an estimated annual sale of USD 1,569 million in the US. Shares of Lupin settled at Rs 662.50 apiece, up 1.49 per cent on the BSE.

Aurobindo Pharma subsidiary's plant gets one observation from USFDA

Aurobindo Pharma on Monday said the US health regulator has issued one observation after inspecting a plant owned by its US-based unit. The US Food and Drug Administration (USFDA) conducted its Pre-Approval Inspection (PAl) and GMP (Good Manufacturing Practice) inspection from August 22-26 of Raleigh-based plant which has been set up for manufacturing MOl (Metered Dose Inhalers) and derma products, the Hyderabad-based drug firm said in a regulatory filing. The plant is owned by Aurolife Pharma LLC, a wholly-owned step down subsidiary of the company, it added. "At the end of the inspection, Aurolife has been issued a 'Form 483' with 1 observation and the observation is procedural in nature and there are no data integrity issues," Aurobindo Pharma said. The company will respond to the USFDA within the stipulated timeline, it added. As per USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its

Still possible to control monkeypox outbreak, says former FDA chief

Former US Food and Drugs Administration (FDA) chief Scott Gottlieb said that the response to the virus has to be wider to control it, though.

Monkeypox endemic in US can be worst public health failure: Ex-FDA director

Monkeypox becoming endemic in the US would be the "worst public health failure in modern times" because it could have been prevented, says former FDA director Scott Gottlieb

Alembic Pharma receive USFDA approval to market drug for skin treatment

Alembic Pharmaceuticals on Friday said its subsidiary has received approval from the US health regulator to market medication for treating actinic keratoses

Glenmark Pharma arm gets final USFDA nod for birth control capsules

Glenmark Pharmaceuticals Ltd on Friday said its US arm has received final approval from the US health regulator for its generic Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate birth control capsules. The approval granted by the US Food & Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc is for Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules of strength 1 mg/20 mcg, the company said in a statement. It is the generic version of Taytulla capsules of Allergan Pharmaceuticals International Ltd, it added. Citing IQVIA sales data for the 12 months ended May 2022, the company said the Taytulla Capsules market achieved annual sales of approximately USD 85.9 million.

Biocon receives three US FDA observations on its Telangana plant

Biotechnology major Biocon on Thursday said the US health regulator has issued three observations after inspecting its Telangana-based manufacturing plant. The US Food and Drug Administration (USFDA) concluded a pre-approval inspection for Site 3 located at Hyderabad on July 20, Biocon Ltd said in a regulatory filing. "Three observations were cited at the end of the inspection, which we will be addressing within the stipulated time," it added. The company stands committed to quality, safety and efficacy of its products, the Bengaluru-based company said.

LIVE: Lankan Prez Gotabaya Rajapaksa headed to Saudi Arabia, says report

Live news upedates: Sri Lanka President Gotabaya Rajapaksa is headed to Saudi Arabia via Singapore

US approves eye drops that could eliminate need for reading glasses

The US has approved a new type of eye drop which they say could eliminate the need for reading glasses

Novavax vaccine gets authorisation for emergency use in adults from USFDA

The US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) for the Novavax Covid-19 vaccine in individuals 18 years of age and older

USFDA authorises pharmacists to prescribe Pfizer's coronavirus pill

Use of the pill which is now authorized to treat newly infected, at-risk people to prevent severe illness, has however jumped in recent weeks as infections rise

US FDA okays for Covid booster targeting Omicron BA.4 and BA.5 variants

The US Food and Drug Administration (FDA) has recommended vaccine manufacturers to develop booster shots against Covid-19 targeting Omicron BA.4 and BA.5 variants

Pfizer's Covid vaccine safe and effective for kids under 5: US FDA

The US Food and Drug Administration (FDA) said that kid-sized doses of Pfizer-BioNTech's COVID-19 vaccine appear to be safe and effective for children under 5-years-old

US FDA's advisory committee endorses Novavax's protein-based Covid shot

The US Food and Drug administration's (FDA) advisory committee has recommended that regulators authorise Novavax's protein-based Covid shot.

FDA advisers back Novavax's Covid vaccine shots as 4th US option

American adults who haven't yet gotten vaccinated against COVID-19 may soon get another choice, as advisers to the Food and Drug Administration on Tuesday backed a more traditional type of shot. Next, the FDA must decide whether to authorise the protein vaccine made by latecomer Novavax as the nation's fourth coronavirus shot for adults. It's made with more conventional technology than today's dominant Pfizer and Moderna shots and the lesser-used Johnson & Johnson option. Novavax shots are already available in Australia, Canada, parts of Europe and multiple other countries, either for initial vaccinations or as mix-and-match boosters. But U.S. clearance is a key hurdle for the Maryland-based company. FDA's vaccine chief Dr. Peter Marks said another choice in the U.S. may entice at least some vaccine holdouts -- whatever their reason -- to consider rolling up their sleeves. We do have a problem with vaccine uptake that is very serious in the United States," Marks said. "Anything w

Baby formula shortage could ease as Abbott reopens Michigan plant

The company said it will begin production of EleCare and other specialty and metabolic formulas, with initial EleCare product release to consumers beginning on or about June 20

US senators push for frequent medical device cybersecurity tips from FDA

Two US senators have proposed a new bill to Congress that seeks FDA to issue cybersecurity guidelines for medical device security more regularly, according to media reports