Jul 07, 2020 07:41 PM IST The company has received abbreviated new drug application (ANDA) approval to market its Cyclobenzaprine Hydrochloride tablets USP 5 mg, 7.5 mg and 10 mg from the United States Food and Drug Administration (USFDA), Unichem Labs said in a filing to the BSE.
Jul 06, 2020 04:49 PM IST Antigen tests are a relatively new type of test for COVID-19 that work by scanning for proteins that can be found on or inside a virus.
Jul 01, 2020 03:15 PM IST The company's product is a generic version of Almirall, LLC's Acticlate tablets in the same strengths, Alembic Pharma said in a BSE filing.
Jun 30, 2020 06:30 PM IST The agency would require drugmakers to show "clearly demonstrated" proof of a vaccine's safety and effectiveness through a clinical study, and at least 50 percent more effectiveness than a placebo, the report said.
Jun 24, 2020 01:12 PM IST The company has received final approval from the United States Food and Drug Administration (USFDA) to market Meclizine hydrochloride tablets in the strengths of 12.5 mg and 25 mg, the company said in a statement.
Jun 24, 2020 12:04 PM IST In a regulatory filing Ipca Laboratories said, the US Food and Drug Administration (USFDA) has informed the company that the "shortage implications for chloroquine phosphate API has changed and chloroquine phosphate drug product is no longer in shortage and therefore, no shipment of API chloroquine phosphate will be excluded from the import alert."
Jun 22, 2020 11:52 AM IST The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) Rivaroxaban tablet is for multiple strengths of 10 mg, 15 mg, and 20 mg, Alembic Pharmaceuticals said in a regulatory filing.
Jun 19, 2020 06:28 PM IST The company has launched Abiraterone Acetate tablets USP in the strength of 250 mg, after the approval from the United States Food and Drug Administration (USFDA), Dr Reddy's Laboratories said in a filing to the BSE.
Jun 19, 2020 02:16 PM IST The approved product is a generic version of Galderma Laboratories LP's Differin gel in the same strength, it added.
Jun 19, 2020 09:57 AM IST "Glenmark Pharmaceuticals Inc, USA has been granted final approval by the United States Food and Drug Administration (USFDA) for Fingolimod Capsules, 0.5 mg, the generic version of Gilenya capsules, 0.5 mg, of Novartis Pharmaceuticals Corporation," the drug major said in a filing to BSE.
Jun 17, 2020 03:20 PM IST The US Food and Drug Administration (FDA) has, for the first time, granted clearance for a video game to be used in treating children with attention deficit hyperactivity disorder (ADHD).
Jun 16, 2020 01:15 PM IST The company has received the final approval from the United States Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Deferasirox tablets in the strength of 180 mg, Alembic Pharmaceuticals said in a BSE filing.
Jun 15, 2020 09:55 PM IST US FDA revoked the authorization following a request from Gary Disbrow, acting director of the Biomedical Advanced Research and Development Authority (BARDA).
Jun 13, 2020 04:20 PM IST As per the non-exclusive licensing agreement, Gilead will grant Dr Reddy's Laboratories the right to register and manufacture its investigational Coronavirus drug remdesivir in 127 countries.
Jun 11, 2020 05:46 PM IST The product is a generic version of Impax Laboratories Inc's Albenza tablets in the same strength, it added.
Jun 08, 2020 12:24 PM IST The Mumbai-based company's drug NaMuscula (mexiletine hydrochloride) is the first and only licensed product to treat myotonia in adults with non-dystrophic myotonic (NDM) disorders.
Jun 05, 2020 01:08 PM IST The company has received final approval from the US Food and Drug Administration (USFDA) to market Atazanavir capsules in strengths of 150 mg, 200 mg and 300 mg, Zydus Cadila said in a statement.
Jun 04, 2020 04:47 PM IST The plant which makes oral solid manufacturing is situated at Dayton, New Jersey and was inspected by the FDA authorities from January 13, 2020 to February 12, 2020.
Jun 02, 2020 05:23 PM IST The company has received approval from the US Food and Drug Administration (USFDA) for meloxicam capsules in strength of 5 mg and 10 mg, Lupin Ltd said in a statement.
Jun 02, 2020 12:20 PM IST The approval is granted to the company's step-down wholly owned subsidiary, Strides Pharma Global, Singapore, by the United States Food and Drug Administration (USFDA) for triamcinolone acetonide ointment USP, 0.05 per cent, Strides Pharma Science said in a regulatory filing.
Jun 01, 2020 06:35 PM IST The agency said it believes the device will be effective at providing temporary right ventricular support, based on clinical experience.
May 28, 2020 03:45 PM IST The company has received the establishment inspection report (EIR) from the US Food and Drug Administration (USFDA) for Medchal-Malkajgiri-based integrated product development organisation (IPDO) indicating closure of the audit, Dr Reddy's Laboratories said in a regulatory filing.
May 27, 2020 10:59 AM IST Glenmark Pharmaceuticals Inc, USA has been granted final approval by the US Food and Drug Administration (USFDA) for Chlorzoxazone tablets USP, in strength of 375 mg and 750 mg, the drug maker said in a statement.
May 21, 2020 09:48 AM IST "It has received final approval for its Abbreviated New Drug Application (ANDA) for Dihydroergotamine Mesylate nasal spray 4mg/mL from the United States Food and Drug Administration (USFDA) with a competitive generic therapy (CGT) designation," the company said in a filing to BSE.
May 18, 2020 10:52 AM IST The company has submitted an abbreviated new drug application (ANDA) for Fluticasone propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg and 500/50 mcg) to the US Food and Drug Administration (USFDA), Cipla said in a regulatory filing.
