US FDA

The US carries out regular inspections at offshore drug making units to ensure quality compliance. In a recent check, the US FDA has issued Form 483 to Sun Pharma Halol unit. Let's demystify Form 483

"We're extremely pleased that we can proceed with our clinical trials for Covaxin our whole virus inactivated COVID-19 vaccine candidate," Dr Shankar Musunuri, CEO and Co-Founder, Ocugen Inc said

The US FDA has granted emergency use authorisation for a booster dose of the Pfizer-BioNTech vaccine for children aged between 5-11 years at least 5 months after completion of primary vaccine series

Drug major Aurobindo Pharma on Wednesday said its wholly-owned subsidiary has received approval from the US health regulator to market anti-cancer medication Bortezomib for injection. Eugia Pharma Specialties has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market the product, a generic equivalent of Takeda Pharmaceuticals' Velcade for injection, the Hyderabad-based company said in a statement. The product, which is indicated for the treatment of multiple myeloma (cancer of plasma cells) and mantle cell lymphoma (cancer of lymph nodes), is being launched immediately, it added. According to IQVIA, the approved product has a market size of USD 1,172 million for the twelve months ending March 2022.

Veklury is approved for young children who are hospitalised, or have mild-to-moderate Covid-19 and are at high risk for progression to severe Covid-19, according to the FDA

The US Food and Drug Administration has approved a fifth Covid-19 booster shot of Pfizer-BioNTech or the Moderna for people aged over 50 and some immunocompromised individuals.

US drug maker Moderna said it will request the Food and Drug Administration (FDA) to grant emergency use authorization for its Covid-19 vaccine to inoculate children under 6 years of age.

Pharmaceuticals firm Indoco Remedies Ltd on Tuesday said it has received final approval from the US health regulator for its generic Lacosamide tablet indicated for prevention and control of seizures. The approval granted by the US Food & Drug Administration (USFDA) for Lacosamide tablets is for strengths of 50 mg, 100 mg, 150 mg and 200 mg. These are the generic version of Vimpat Tablets of UCB Inc, the company said in a regulatory filing. Indoco Remedies Managing Director Aditi Kare Panandikar said, "The ANDA approval for Lacosamide Tablets on the day of patent expiry, reverberates our enduring commitment to make quality and affordable generic medicines available to more patients in the United States. Our first shipment of Lacosamide tablets has already reached the US". Lacosamide tablets are indicated for the prevention and control of seizures. It is an anticonvulsant/antiepileptic drug, the company said. Citing IQVIA sales data for the period ending January 2022, the company ..

Moderna submitted a request to the US Food and Drug Administration (FDA) for emergency use authorization on a fourth dose of its COVID-19 vaccine for adults 18 years of age and older

Drugmaker Moderna asked the Food and Drug Administration on Thursday to authorize a fourth shot of its COVID-19 vaccine as a booster dose for all adults. The request is broader than rival pharmaceutical company Pfizer's request earlier this week for the regulator to approve a booster shot for all seniors. In a press release, the company said its request for approval for all adults was made to provide flexibility to the Centers for Disease Control and Prevention and medical providers to determine the appropriate use of a second booster dose of the mRNA vaccine, including for those at higher risk of COVID-19 due to age or comorbidities." U.S. officials have been laying the groundwork to deliver additional booster doses to shore up the vaccines' protection against serious disease and death from COVID-19. The White House has been sounding the alarm that it needs Congress to urgently approve more funding for the federal government to secure more doses of the COVID-19 vaccines, either fo

In a statement on Monday, Bharat Biotech and its US partner Ocugen expressed their commitment towards bringing Covaxin to the US and Canada for all age group

Bharat Biotech's US partner Ocugen said it intends to continue working with the US FDA to evaluate the process for getting an EUA for pediatric use of Covaxin

Drug maker Lupin on Tuesday said it has launched Sevelamer Hydrochloride tablets (800 mg), used to treat hyperphosphatemia in patients with chronic kidney disease, in the US market

Glenmark Pharmaceuticals Limited said its subsidiary Glenmark Specialty S.A. has received US FDA approval for nasal spray fixed dose prescription drug for seasonal allergic rhinitis Ryaltris.

The FDA approved the drug in June despite its committee of outside experts voting in November 2020 that the drug should not be approved.

The drug, to be available under the brand name Quviviq, was approved in doses of 25 mg and 50 mg based on data from two late-stage trials

Cadila Healthcare on Friday said its US arm Zydus Pharmaceuticals (USA) Inc has received tentative approval from the US health regulator to market generic Pimavanserin capsules, indicated for treatment of hallucinations and delusions associated with Parkinson's disease psychosis. The approval by the US Food & Drug Administration for the generic Pimavanserin capsules is for the strength of 34 mg, Cadila Healthcare said in a regulatory filing. "The drug will be manufactured at the group's formulation manufacturing facility at SEZ Ahmedabad," it said. The group now has 325 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04, it added.

The Food and Drug Administration in the US has said that rapid antigen tests are less sensitive for detecting Omicron variant infections

The US Food and Drug Administration (FDA) on Wednesday (local time) authorized Pfizer's Paxlovid COVID-19 pill for high-risk people aged 12 and over to treat coronavirus disease (COVID-19)."The US Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer's Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death," US Food and Drug said in a statement."Today's authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally -- a major step forward in the fight against this global pandemic," said Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and

The Food and Drug Administration is loosening some restrictions on where women can obtain abortion pills, including a long-standing requirement that the medication be picked up in person