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Alembic Pharmaceuticals receives USFDA Tentative Approval for Ivabradine Tablets, 5 mg and 7.5 mg

 

 

 

 

Alembic Pharmaceuticals receives USFDA Tentative Approval for Ivabradine Tablets, 5 mg and 7.5 mg.Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ivabradine Tablets, 5 mg and 7.5 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Corlanor Tablets, 5 mg and 7.5 mg, of Amgen Inc. (Amgen). Ivabradine Tablets are indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction ≤ 35%, who are in sinus rhythm with resting heart rate ≥ 70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use. Ivabradine Tablets are indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses. Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US$ 102 million for twelve months ending December 2021 according to IQVIA. Alembic has received a cumulative total of 164 ANDA approvals (140 final approvals and 24 tentative approvals) from USFDA.

 

 

 

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic’s state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic’s brands, marketed through a marketing team of over 5000 are well recognized by doctors and patients. Information about Alembic can be found at https://www.alembicpharmaceuticals.com/; (Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLLTD) (BSE: 533573)

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Lupin gets USFDA nod for generic product

Drug firm Lupin on Saturday said it has received approval from the US health regulator to market Sevelamer Carbonate for Oral Suspension, used in the control of serum phosphorus with chronic kidney disease (CKD) on dialysis.

 


The company has received approval from the United States Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) Sevelamer Carbonate for Oral Suspension in the American market, Lupin said in a statement.

This product will be manufactured at the company’s Goa facility, it added.

As per IQVIA MAT September 2021 data, Sevelamer Carbonate for Oral Suspension had estimated annual sales of USD 51.7 million in the US.

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Alembic Pharmaceuticals recieves USFDA approval for Opthalmic Solution.

Drug firm Alembic Pharmaceuticals on Wednesday said it has received approval from the US health regulator for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution, used to treat certain types of glaucoma and other causes of high pressure inside the eye.

The approved product is therapeutically equivalent to the reference listed drug product (RLD) Cosopt Ophthalmic Solution, 2 per cent and 0.5 per cent, of Akorn Operating Company LLC.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2 per cent and 0.5 per cent, Alembic Pharmaceuticals said in a regulatory filing.

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.

Quoting IQVIA data, Alembic Pharma said Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2 per cent and 0.5 per cent has an estimated market size of USD 80 million for twelve months ending December 2020.

Alembic now has a total of 143 ANDA approvals (125 final approvals and 18 tentative approvals) from

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Alembic Global Holding SA receives USFDA Final Approval for Treprostinil Injection

Alembic Pharmaceuticals announces its wholly-owned subsidiary, Alembic Global Holding SA receives USFDA Final Approval for Treprostinil Injection, 20 mg/20 mL (1 mg/mL), 50 mg/20 mL (2.5 mg/mL), 100 mg/20 mL (5 mg/mL), and 200 mg/20 mL (10 mg/mL), Multiple-Dose Vials.

Alembic Pharmaceuticals Limited today announced that its wholly-owned subsidiary Alembic Global Holding SA has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Treprostinil Injection, 20 mg/20 mL (1 mg/mL), 50 mg/20 mL (2.5 mg/mL), 100 mg/20 mL (5 mg/mL), and 200 mg/20 mL (10 mg/mL), Multiple-Dose Vials. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Remodulin Injection, 20 mg/20 mL (1mg/mL), 50 mg/20 mL (2.5 mg/mL), 100 mg/20 mL (5 mg/mL), and 200 mg/20 mL (10mg/mL), of United Therapeutics Corp. (United). Treprostinil Injection is indicated for the treatment of pulmonary arterial hypertension (PAH;WHO Group 1) to diminish symptoms associated with exercise. In patients with PAH requiring transition from epoprostenol, Treprostinil Injection is indicated to diminish the rate of clinical deterioration. Alembic had previously received tentative approval for this ANDA.

Treprostinil Injection has an estimated market size of US$ 17 million for twelve months ending December 2020 according to IQVIA.

Alembic now has a total of 138 ANDA approvals (121 final approvals and 17 tentative approvals) from USFDA, including this first injectable ANDA approval.

About Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic’s state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic’s brands, marketed through a marketing team of over 5000 are well recognized by doctors and patients.

Information about Alembic can be found at http://www.alembicpharmaceuticals.com/; (Reuters: ALEM.NS) (Bloomberg: ALPM) (NSE: APLLTD) (BSE: 533573)