Alembic Pharma gets tentative USFDA nod for breast cancer treatment drug

 Drug firm Alembic Pharmaceuticals on Monday said it has received tentative approval from the US health regulator for Palbociclib capsules, used to treat a certain type of breast cancer.

The approved product is therapeutically equivalent to the reference listed drug product lbrance Capsules of Pfizer Inc.

"The company has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) in the strengths of Palbociclib capsules, 75 mg, 100 mg, and 125 mg," Alembic Pharmaceuticals said in a regulatory filing.

Alembic said it is currently in litigation with Pfizer in District Court of Delaware and launch of the product will depend on litigation outcome.

Citing IQVIA data, Alembic Pharma said Palbociclib capsules, 75 mg, 100 mg, and 125 mg, have an estimated market size of USD 624 million for 12 months ending June 2020.

Alembic Pharma now has a total of 135 ANDA approvals (117 final approvals and 18 tentative approvals) from USFDA.

Alembic Pharma gets USFDA nod for anti-viral drug Amantadine Hydrochloride

 Drug firm Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator for Amantadine Hydrochloride tablets, used for treatment ofinfluenza A virus.

The approved product is therapeutically equivalent to the reference listed drug product Symmetrel tablets of Endo Pharmaceuticals, Inc.

In a regulatory filing, Alembic Pharmaceuticals said "it has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Amantadine Hydrochloride tablets in the strength of 100 mg".

Amantadine Hydrochloride tablets are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus.

Quoting IQVIA data, Alembic Pharma saidAmantadine Hydrochloride Tablets, 100 mg have an estimated market size of USD 13 million for twelve months ending June, 2020.

IQVIA is an American multi-national company serving the combined industries of health information technology and clinical research.

Alembic now has a total of 132 ANDA approvals (114 final approvals and 18 tentative approvals) from USFDA.

Alembic Pharma's Aleor Dermaceuticals gets USFDA nod for generic product

Drug firm Alembic Pharmaceuticals on Wednesday said its joint venture firm Aleor Dermaceuticals has received approval from the US health regulator to market a generic product, which is used to treat various skin conditions, in the American market.

The company said its joint venture firm Aleor has received final approval from the US Food and Drug Administration (USFDA) to market its abbreviated new drug application (ANDA) Clobetasol Propionate Cream in the US market.

The approved product is generic version of Fougera Pharmaceuticals' Temovate Cream which is indicated for relief of inflammatory and pruritic manifestations.

According to IQVIA, the Clobetasol Propionate Cream USP (0.05 per cent) had an estimated market size of USD 57 million (about Rs 405 crore) for the 12-months ending September 2019.

Alembic now has a cumulative total of 118 ANDA approvals from the USFDA.

The company's shares on Wednesday ended 0.41 per cent higher at Rs 634.30 on the BSE.

Alembic Pharma gets final nod from USFDA for infection treatment drug

Drug firm Alembic Pharmaceuticals on Tuesday said it has received a final nod from the US health regulator for Azithromycin tablets, used for the treatment of infections.

"Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Azithromycin Tablets USP, 600 mg," the drug firm said in a filing to BSE.

Azithromycin tablet is a macrolide antibacterial drug indicated for mild to moderate infections.

The approved ANDA is therapeutically equivalent to the reference listed drug product Zithromax tablets, 600 mg, of Pfizer, the filing said.

Citing IQVIA, the company said Azithromycin tablets USP, 600 mg have an estimated market size of $2 million for 12 months ending September 2019.

Alembic Pharmaceuticals has a cumulative total of 115 ANDA approvals (103 final approvals and 12 tentative approvals) from USFDA.

The shares of the company were trading at Rs 628.35 a piece on BSE in morning trade, up 2.20 per cent from the previous close.

Alembic Pharma gets final nod from US regulator for Fenofibrate tablets

Alembic Pharmaceuticals on Thursday said it has received final nod from the US health regulator for fenofibrate tablets, which reduces cholesterol and triglycerides in blood.

"Alembic Pharmaceuticals Limited (Alembic)...has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fenofibrate Tablets USP, 54 mg and 160 mg.

"The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Tricor Tablets, 54 mg and 160 mg, of AbbVie Inc (AbbVie)," the drug firm said in a BSE filing.

Fenofibrate tablets have an estimated market size of $100 million for twelve months ending September 2019, according to IQVIA.

"Fenofibrate tablets are indicated as an adjunct to diet to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidaemia and for treatment of adult patients with severe hypertriglyceridemia," it said.

Alembic has a cumulative total of 113 ANDA approvals -- 100 final approvals and 13 tentative approvals -- from the USFDA.

Alembic gets USFDA nod for Tizanidine hydrochloride capsules for spasticity

Drug firm Alembic Pharmaceuticals on Wednesday said it has received final nod from the US health regulator for Tizanidine hydrochloride capsules, used to treat spasticity.

"The company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg," the drug firm said in a regulatory filing.

Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity.

Because of the short duration of therapeutic effect, treatment with tizanidine hydrochloride capsules should be reserved for those daily activities and times when relief of spasticity is most important.

"The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Zanaflex Capsules, 2 mg, 4 mg, and 6 mg, of Covis Pharma BV," the filing said.

Tizanidine hydrochloride capsules, 2 mg, 4 mg, and 6 mg have an estimated market size of USD 28 million for twelve months ending September 2019 according to IQVIA.

Alembic has a cumulative total of 111 ANDA approval -- 99 final approvals and 12 tentative approvals -- from USFDA.

The shares of Alembic Pharmaceuticals Ltd were trading at Rs 573, up 1.96 per cent on BSE in morning trade.

Alembic Pharma gets USFDA nod for Parkinson's disease treatment drugs

The approved products are therapeutically equivalent to the reference listed drug Sinemet CR tablets of Merck Sharp & Dohme Corp.

The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application Carbidopa and Levodopa extended-release tablets in the strengths of 2.5 mg/100 mg and 50mg/200 mg, Alembic said in a BSE filing.

Quoting IQVIA sales data, the company said the two products had an estimated market size of $24 million for 12 months ended December 2018.

The company said it now has a total of 94 abbreviated new drug application (ANDA) approvals from the USFDA.

Shares of Alembic Pharmaceuticals were trading at Rs 511.05 apiece, down 0.08 per cent, on the BSE.