Page 5 - Us Fda

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 ...

US FDA rejected Musk-run Neuralink's bid to implant chip in human brain

The US Food and Drug Administration (FDA) rejected Elon Musk-run company Neuralink's bid to implant a chip in a human brain over safety risks, the media reported.

CDSCO probes Indian eyedrops after US FDA flags contamination risk

Global Pharma has initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma's Artificial Tears

US FDA joins global regulators probing tainted overseas cough syrup

The agency seeks more information about the specific raw materials used and whether they were obtained from any of the same suppliers

Lupin Digital launches Lyfe, a 24x7 monitoring ecosystem for heart patients

Company aims to onboard one million patients the platform, which aims to help them improve heart health through doctor-connected online and offline modules

Once science fiction, lab-grown meat coming to US restaurants this year

Executives at cultivated meat firms are optimistic that meat grown in massive steel vats could be on the menu within months after a company won the go-ahead from a key regulator

Abbott faces criminal investigation over baby formula, says report

The Michigan plant came to national attention in 2022 after FDA, while fielding reports of infants sickened by formula produced there, found strikingly unsanitary co

Lupin gets USFDA tentative nod for generic drugs to treat HIV infection

Pharmaceutical firm Lupin on Monday said it has received tentative approval from the US health regulator to market its generic version of Dolutegravir and Rilpivirine tablets used in treatment of HIV infection. The tentative approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Dolutegravir and Rilpivirine tablets of strength 50 mg/25 mg, Lupin said in a regulatory filing. The Dolutegravir and Rilpivirine tablets, 50 mg/25 mg had estimated annual sales of USD 666 million in the US, the company said citing IQVIA MAT September 2022 data.

US FDA finalises rule allowing women to get abortion pills via mail-order

The Food and Drug Administration on Tuesday finalised a rule change that allows women seeking abortion pills to get them through the mail, replacing a long-standing requirement that they pick up the medicine in person. The Biden administration implemented the change last year, announcing it would no longer enforce the dispensing rule. Tuesday's action formally updates the drug's labelling to allow women to get a prescription via telehealth consultation with a health professional, and then receive the pills through the mail, where permitted by law. Still, the rule change's impact has been blunted by numerous state laws limiting abortion broadly and the pills specifically. Legal experts foresee years of court battles over access to the pills, as abortion-rights proponents bring test cases to challenge state restrictions. For more than 20 years, the FDA labelling had limited dispensing to doctor's offices and clinics, due to safety concerns. During the COVID-19 pandemic, the FDA ...

Sun Pharmaceuticals' Halol plant gets 'import alert' from USFDA

The USFDA had imposed an import ban on the Halol plant in December 2015 too

Sun Pharma Q2 PAT rises 10.5% YoY to Rs 2,262 crore on robust sales

Gross sales came in at Rs 10,809.2 crore, growing by 13.1% over Q2 last year