Alembic Pharma gets Final USFDA nod for Doxycycline Hyclate Tablets Ruchika Sharma2 July 2020 11:45 AM ISTDoxycycline Hyclate Tablets, 75 mg and 150 mg are indicated for the treatment of certain Rickettsial, sexually transmitted, respiratory tract,...
Merck bladder cancer treatment BAVENCIO gets USFDA approval Farhat Nasim1 July 2020 12:30 PM ISTNew York: EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. today announced that the...
Merck goes against Dr Reddys alleging patent infringement of diabetes drug Januvia, Janumet Farhat Nasim28 Jun 2020 10:45 AM ISTMerck in its petition filed on June 23, said Dr Reddys had submitted ANDAs (abbreviated new drug application) to the US FDA seeking approval from the...
Import ban on Ipca Labs API for chloroquine phosphate reinforced by USFDA Ruchika Sharma25 Jun 2020 1:00 PM ISTIn a regulatory filing Ipca Laboratories said, the US Food and Drug Administration (USFDA) has informed the company that the "shortage implications...
Zydus Cadila gets USFDA nod to antihistamine Meclizine Hydrochloride Tablets Ruchika Sharma25 Jun 2020 12:25 PM ISTMeclizine is an antihistamine that is used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness. It may also be used to...
Alembic Pharma gets tentative USFDA nod for Rivaroxaban Tablets Ruchika Sharma23 Jun 2020 11:23 AM ISTThe approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Xarelto Tablets, 10 mg, 15 mg, and 20 mg, of Janssen...
Lupin, Unichem recall BP drugs in US over quality issue Ruchika Sharma22 Jun 2020 12:02 PM ISTThe Class-II recall is on account of "Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle," the report said.
Alembic Pharma JV Aleor Dermaceuticals gets USFDA nod for Adapalene Gel Ruchika Sharma20 Jun 2020 12:19 PM ISTAdapalene Gel USP, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
Alembic Pharma gets USFDA EIR for Panelav facility Ruchika Sharma20 Jun 2020 10:00 AM ISTNew Delhi: Alembic Pharmaceuticals on Friday said it has received establishment inspection report (EIR) from the US health regulator for its...
Glenmark Pharmaceuticals gets USFDA nod for Fingolimod Capsules Ruchika Sharma19 Jun 2020 3:14 PM ISTMumbai: Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (U.S. FDA)...
Novartis Cosentyx gets USFDA nod to treat active non-radiographic axial spondyloarthritis Ruchika Sharma17 Jun 2020 5:43 PM ISTCosentyx met the primary endpoint achieving statistically significant improvements versus placebo in the signs and symptoms of nr-axSpA, as measured...
Zydus Cadila gets final USFDA nod for Deferasirox Tablets to treat iron overload syndrome Ruchika Sharma17 Jun 2020 10:58 AM ISTIt is used to treat iron overload caused by blood transfusions in adults and children who are at least 2 years old.
