Page 4 - Us Fda

Aurobindo Pharma's new injectable facility get 10 observations from US FDA

"The observations are procedural and will be responded to within the stipulated time," the company stated in a regulatory filing

Zydus Lifesciences gets six observations from USFDA for API plant

Zydus Lifesciences on Friday said the US health regulator has issued six observations after inspecting its active pharmaceutical ingredient (API) site in Ahmedabad, Gujarat. The US Food and Drug Administration (USFDA) conducted the inspection from December 14 to December 22, 2023. The inspection closed with six observations, Zydus Lifesciences said in a regulatory filing. There were no data integrity related observations, it added. Besides, there are no repeat observations from the previous inspection, it noted. There are four drug master files (DMFs) from the site under approval with the USFDA, the drugmaker said. The company will closely work with the USFDA to address the observations, it added.

First gene-editing therapy for sickle cell disease approved by US FDA

The agency approved Lyfgenia from bluebird bio, and a separate treatment called Casgevy by partners Vertex Pharmaceuticals and Crispr Therapeutics

Strides Pharma arm obtains USFDA nod for Levetiracetam oral solution

According to market research firm IQVIA, the Levetiracetam oral solution has a market size of $55 million

First chikungunya vaccine, Ixchiq, approved by US FDA for people above 18

Ixchiq, the first chikungunya vaccine, has been approved by the US Food and Drug Administration (FDA) for individuals 18 years of age and older who are at increased risk of exposure to mosquito-borne virus. Containing a live, weakened version of the chikungunya-causing virus, Ixchiq is administered as a single dose by injection into the muscle and may cause symptoms in the recipient similar to those experienced by people having the viral disease, the FDA said in a statement. "Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "Today's approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options," said Marks. The effectiveness of the vaccine was determined through a clinical study

US approves 1st vaccine against chikungunya virus: All you need to know

Symptoms of chikungunya can sometimes last for months or even years, but the virus is rarely fatal

Glenmark gets USFDA nod to market generic version of Otezla tablets

Glenmark's current portfolio includes a total of 188 products that have been authorised for distribution in the US marketplace

Lupin receives tentative approval from US FDA for apalutamide tablets

Lupin develops and commercialises a wide range of branded and generic formulations, biotechnology products, and Active Pharmaceutical Ingredients (APIs) in over 100 markets

Sun Pharma, Aurobindo recall drugs from US market due to mfg issues

Leading drug makers Sun Pharmaceutical Industries and Aurobindo Pharma are recalling products from the US market due to manufacturing issues, according to the US Food & Drug Administration. As per the latest Enforcement Report issued by the American health regulator, a US-based subsidiary of Mumbai-based Sun Pharma is recalling 69,707 cartons of Cequa (cyclosporine ophthalmic solution) from the US market. The medication is used for the treatment of dry eyes. New Jersey-based Sun Pharmaceutical Industries Inc is recalling the product for being "Subpotent', USFDA stated. The company initiated the nationwide (US) Class III recall on September 7 this year. As per the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences". The US health regulator stated that Aurobindo Pharma is recalling 9,890 bottles of Rasagiline Tablets, a medication indicated for the treatment of Parkinson's ..

FDA has accepted NDA for dermatological drug Deuruxolitinib: Sun Pharma

Sun Pharmaceutical Industries Ltd said that it had submitted an 8mg twice-daily regimen of deuruxolitinib for FDA review

Lupin gets EIR Status from US FDA for Nagpur Unit-1 manufacturing facility

The EIR was issued following the facility's inspection conducted in July 2023

Lupin gets thumbs up from USFDA to market generic medication in US

Drug firm Lupin on Friday said its unit has received approval from the US health regulator to market a medication to treat various disorders like schizophrenia. The company's Somerset-based wholly-owned subsidiary Lupin Inc has received approval from the US Food and Drug Administration (USFDA) for Chlorpromazine Hydrochloride tablets, Lupin said in a statement. The Mumbai-based drug maker's product is the generic version of Upsher-Smith Laboratories, LLC's product. As per IQVIA MAT data, Chlorpromazine Hydrochloride Tablets had an estimated annual sale of USD 45 million in the US.

First over-the-counter birth control pill gets FDA approval in US

US officials have approved the first over-the-counter birth control pill, which will let American women and girls buy contraceptive medication from the same aisle as aspirin and eyedrops. The Food and Drug Administration said Thursday it cleared Perrigo's once-a-day Opill to be sold without a prescription, making it the first such medication to be moved out from behind the pharmacy counter. The company won't start shipping the pill until early next year, and there will be no age restrictions on sales. Hormone-based pills have long been the most common form of birth control in the US, used by tens of millions of women since the 1960s. Until now, all of them required a prescription. Medical societies and women's health groups have pushed for wider access, noting that an estimated 45% of the 6 million annual pregnancies in the US are unintended. Teens and girls, women of colour and those with low incomes report greater hurdles in getting prescriptions and picking them up. Some of the

Pharma major Lupin receives approval from US FDA for diazepam rectal gel

Diazepam Rectal Gel had estimated annual sales of $34 million in the US

Elon Musk's Neuralink says it has US FDA approval for human trials

Neuralink isn't the first brain-computer interface company to enter human trials, and the field has become competitive since the company's founding

USFDA puts on hold Sun Pharma trials on dermatological drug regimen

The US health regulator has directed Sun Pharma to stop trials of a dermatological drug with a 12 mg dose regimen as its usage could lead to blood clots. The drug major on Tuesday said it had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose in one of the long-term Open Label Extension (OLE) studies. As a result, the agency has placed the investigational new drug (IND) on partial clinical hold due to the potential for thrombotic events and is requiring that subjects currently on the 12 mg dose in the OLE studies discontinue that dose, it added. There have been no thrombotic events reported to date for the 8 mg dose and USFDA has not placed the 8 mg dose on hold, the drugmaker said in a regulatory filing. "We are taking immediate steps to transition the patients in the OLE studies to the 8 mg BID dose arm in the ongoing studies," Sun Pharmaceutical Industries stated. No ...

US FDA panel backs restricted use of AstraZeneca's prostate cancer drug

Lynparza is already approved by the FDA to treat a type of breast cancer, ovarian cancer, as well as a different form of prostate cancer

FDA clears extra Covid-19 booster dose for some high-risk Americans

US regulators on Tuesday cleared another booster dose of the Pfizer or Moderna COVID-19 vaccines for older Americans and people with weak immune systems. The Food and Drug Administration also took steps to make coronavirus vaccinations simpler for everyone, saying that anyone getting a Pfizer or Moderna dose whether it's a booster or their first-ever vaccination will get the newest formula, not the original shots. The FDA said those 65 or older can opt to roll up their sleeves again for another booster as long as it's been at least four months since their first dose of the so-called bivalent vaccine that targets omicron strains. And most people who are immune-compromised also can choose that extra spring booster at least two months after their first, with additional doses in the future at the discretion of their physician, the agency said. If the Centers for Disease Control and Prevention signs off, those spring boosters could begin within days. The CDC's advisers are set to meet

Amid US watchdog heat, it is life as usual at Global Pharma'S Chennai unit

The firm ran into trouble after the US FDA informed it of 55 cases of adverse events on the use of its eye drops, some of which caused permanent loss of vision and at least one caused death

Zydus recalls over 55k bottles of generic drug used to treat gout in US

Drug firm Zydus Lifesciences is recalling over 55,000 bottles of generic medication in the US market due to failed impurities specifications. As per the latest enforcement report by the US Food and Drug Administration (USFDA), Zydus Pharmaceuticals (USA) Inc is recalling 21,936 (30 count) and 33,096 (100 count) bottles of Colchicine tablets, which are used to treat gout. The affected lot is manufactured by Ahmedabad-based Zydus Lifesciences and marketed in the US by New Jersey-based Zydus Pharmaceuticals (USA) Inc. USFDA said the company is recalling the product due to "failed impurities/ degradation specifications". An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine, it added. Zydus commenced the Class III recall on February 24 this year. As per the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health ...