Caplin Point Laboratories announced that its subsidiary, Caplin Steriles has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application
(ANDA) Argatroban Injection, 50 mg/50 ml (1 mg/ml) Single-dose vial presentation, a generic therapeutic equivalent version of (RLD), ARGATROBAN INJECTION, of Hikma Pharmaceuticals.
Caplin has received a CGT (Competitive Generic Therapies) Grant for this ANDA and Caplin is the first approved applicant for such competitive generic therapy, as defined in section 505(j)(5)(B)(v)(III) of the FD&C Act.
Therefore, with this approval, Caplin is eligible for 180 days of CGT exclusivity for Argatroban Injection, 50 mg/50 ml (1 mg/ml) Single- Dose Vial, under section 505(j)(5)(B)(v) of the FD&C Act.
Unichem Laboratories gained 1.15% to Rs 280.85 after the company said it received US drug regulator s approval for celecoxib capsules, an anti-inflammatory drug.
In a regulatory filing made during market hours today, the company said that it had received ANDA approval for its Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg from the United States Food and Drug Administration (US FDA). The product is a generic version of Celebrex capsules of G.D. Searle LLC, Division of Pfizer Inc.
Celecoxib capsules are indicated for treatment of osteoarthritis, rheumatoid arthritis juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain and primary dysmenorrhea. The product will be commercialized from Unichem s Goa Plant, the company said in a statement.
and improve daily physical function so moving is easier. because just one 200mg celebrex a day can provide 24 hour relief for many with arthritis pain. and it s not a narcotic. you and your doctor should balance the benefits with the risks. all prescription nsaids, like celebrex, ibuprofen, naproxen and meloxicam have the same cardiovascular warning. they all may increase the chance of heart attack or stroke, which can lead to death. this chance increases if you have heart disease or risk factors such as high blood pressure or when nsaids are taken for long periods. nsaids, like celebrex, increase the chance of serious skin or allergic reactions, or stomach and intestine problems, such as bleeding and ulcers, which can occur without warning and may cause death. patients also taking aspirin and the elderly are at increased risk for stomach bleeding and ulcers. don t take celebrex if you have bleeding in the stomach or intestine, or had an asthma attack, hives, other allergies to aspirin
if you have bleeding in the stomach or intestine, or had an asthma attack, hives, other allergies to aspirin, nsaids or sulfonamides. get help right away if you have swelling of the face or throat, or trouble breathing. tell your doctor your medical history. and find an arthritis treatment for you. visit celebrex.com and ask your doctor about celebrex. for a body in motion. visit celebrex.com and ask your doctor about celebrex. yobut you may notds. know we re a family. 12 brands. more hotels than anyone else in the world. like days inn, where you can do everything under the sun. save up to 15 percent and earn bonus points when you book at wyndhamrewards.com
and it s not a narcotic. you and your doctor should balance the benefits with the risks. all prescription nsaids, like celebrex, ibuprofen, naproxen and meloxicam have the same cardiovascular warning. they all may increase the chance of heart attack or stroke, which can lead to death. this chance increases if you have heart disease or risk factors such as high blood pressure or when nsaids are taken for long periods. nsaids, like celebrex, increase the chance of serious skin or allergic reactions, or stomach and intestine problems, such as bleeding and ulcers, which can occur without warning and may cause death. patients also taking aspirin and the elderly are at increased risk for stomach bleeding and ulcers. don t take celebrex if you have bleeding in the stomach or intestine, or had an asthma attack, hives, other allergies to aspirin, nsaids or sulfonamides. get help right away if you have swelling of the face or throat, or trouble breathing. tell your doctor your medical history an