Aurobindo Pharma gets USFDA gesture for conventional Droxidopa capsules Kumar Jeetendra | February 20, 2021 New Delhi: Drug major Aurobindo Pharma on Friday said it has received final approval from the US health regulator to manufacture and market Droxidopa capsules, used to treat dizziness and lightheadedness. The approved product is a generic version of Lundbeck NA Ltd’s Northera capsules. The business has received final approval from the US Food and …
Alembic Pharma gets USFDA gesture for bipolar depression drug Kumar Jeetendra | May 15, 2021 New Delhi, May 14 (PTI) Drug firm Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for Lurasidone Hydrochloride tablets, used to treat bipolar depression. The approved product is therapeutically equivalent to the reference listed drug product (RLD) Latuda tablets of Sunovion Pharmaceuticals Inc. The company has received approval …
Cipla receives final approval for generic version of Sunovion Pharmaceuticals, Inc.’s Arformoterol Tartrate Inhalation Solution Kumar Jeetendra | June 23, 2021 Mumbai, India, June 23, 2021: Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”) today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Arformoterol Tartrate Inhalation Solution 15 mcg / 2 mL from the United States Food and Drug Administration (US FDA). Cipla’s Arformoterol …
Glenmark Pharma gets USFDA gesture for inhaltion drug Kumar Jeetendra | June 23, 2021 Drug maker Glenmark Pharma on Wednesday said it had received approval from the US health regulator for Arformoterol Tartrate Inhalation Solution, used to treat conditions like chronic bronchitis and emphysema, in the US market. The approved product is a generic version of Brovana Inhalation Solution, 15 mcg/2 mL, of Sunovion Pharmaceuticals Inc. “Glenmark Pharmaceuticals has …
Alembic Pharmaceuticals receives USFDA Final Approval for Doxycycline Hyclate Delayed-Release Tablets USP, 75 mg, 100 mg, 150 mg, and 200 mg. Kumar Jeetendra | January 4, 2022 4th January, 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Hyclate Delayed-Release Tablets USP, 75 mg, 100 mg, 150 mg, and 200 mg. The approved ANDA is therapeutically equivalent to the reference …
Alembic Pharmaceuticals receives USFDA Final Approval for Entacapone Tablets USP, 200 mg. Kumar Jeetendra | January 6, 2022 6th January, 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Entacapone Tablets USP, 200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Comtan Tablets, 200 mg, of …
Glenmark Pharma arm gets last USFDA endorsement for blood pressure drug Kumar Jeetendra | January 27, 2022 Glenmark Pharmaceuticals Ltd announced that its U.S. subsidiary received final approval by the country’s regulator for generic Bisoprolol fumarate and Hydrochlorothiazide tablets to treat high blood pressure. According to a statement, Glenmark Pharmaceuticals Inc., U.S.A was granted approval for Bisoprolol Fumarate tablets in strengths of 2.5 mg/6.25mg, 5 mg/6.25mg, and 10 mg/6.25 MG. These generic …
Alembic Pharmaceuticals announces USFDA Tentative Approval for Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg. Kumar Jeetendra | April 7, 2022 7th April, 2022, Mumbai: Alembic Pharmaceuticals Limited today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) …
Alembic Pharmaceuticals receives USFDA Final Approval for Pirfenidone Tablets, 267 mg and 801 mg. Kumar Jeetendra | May 25, 2022 24 May 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Pirfenidone Tablets, 267 mg and 801 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Esbriet Tablets, 267 …
Alembic Pharmaceuticals announces its wholly owned subsidiary, Aleor Dermaceuticals Limited receives USFDA Final Approval for Diclofenac Sodium Topical Gel, 3%. Kumar Jeetendra | August 1, 2022 Alembic Pharmaceuticals Limited (Alembic) today announced that its wholly owned subsidiary, Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Topical Gel, 3%.The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Solaraze Topical Gel, …
Aleor Dermaceuticals Limited receives USFDA Final Approval for Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%. Kumar Jeetendra | August 8, 2022 Alembic Pharmaceuticals Limited (Alembic) today announced that its wholly owned subsidiary, Aleor Dermaceuticals Limited (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) …
Cipla receives USFDA approval for generic version of Revlimid® (lenalidomide capsules) Kumar Jeetendra | September 7, 2022 Mumbai, India/ New Jersey, United States, September 7, 2022: Cipla Limited (BSE: 500087; NSE: CIPLA EQ) (“Cipla”) announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsule 5 mg, 10 mg, 15 mg and 25 mg from the United States Food and Drug Administration (US FDA). Cipla’s Lenalidomide …
