Alembic Pharma gets two approvals from USFDA

Alembic Pharmaceuticals said it received approvals from the United States Food and Drug Administration (USFDA) for sales of a therapeutic equivalent of French pharma major Sanofi Aventis’ Aubagio tablets and for a therapeutic equivalent of Novartis Pharmaceuticals Corporation’s Tobrex Ophthalmic Solution. Teriflunomide pills are used to reduce flare-ups in people with relapsing multiple sclerosis (MS). […]

Granules India gets nod for paracetamol tablets in USA

Pharmaceutical manufacturer Granules India Ltd said that it has received approval from the United States Food and Drug Administration to sell a bioequivalent version of Johnson & Johnson’s Tylenol tablets. Acetaminophen Extended Release tablets, also known as Paracetamol, are used primarily for temporary pain management, including arthritis relief. It will be sold in doses of […]

Alembic Pharma gets USFDA nod for generic Lumigan eye drops

Alembic Pharmaceuticals said it has received approval from the US Food & Drug Administration (USFDA) to sell an equivalent drug of Lumigan eye drops of Allergan. Bimatoprost Ophthalmic Solution 0.03% has an estimated US market size of $ 76 million. It is indicated for the reduction of elevated intraocular pressure in patients with open angle […]

Caplin Sterlites to supply products to Baxter International

Indian pharmaceutical manufacturer Caplin Point Laboratories said that its  wholly-owned subsidiary Caplin Sterlites Ltd signed a licence and supply agreement with US healthcare firm Baxter International for sales of five generic injectable drugs. Under the agreement, Caplin will be supplying its products to Baxter for sales. “All these ANDAs [generic drugs] have been developed in-house, […]

Zydus Cadila receives tentative USFDA nod for generic Vimpat tablets

Pharmaceutical manufacturer Zydus Cadila said that it received tentative approval from the US Food and Drug Administration for sales of a generic equivalent of UCB Inc’s Vimpat tablets. A tentative approval means that the company has to wait for all patent and other protections to expire before starting the sale of the drug. Lacosamide is […]

Zydus Cadila receives tentative USFDA nod for overactive bladder drug

Pharmaceutical manufacturer Zydus Cadila said that it has received tentative approval from the US Food and Drug Administration for sales of mirabegron extended-release tablets. A tentative approval means that the company has to wait for all patent and other protections to expire before starting the sale of the drug. The tablets, currently sold under the […]

Strides Pharma to launch Potassium Chloride Extended-Release markets in US market

Pharmaceutical Strides Pharma Science Ltd said wholly owned subsidiary Vensun Pharmaceuticals and partner Pharmaceutics International received approval from the United States Food and Drug Administration to launch a generic equivalent of Merck’s potassium chloride extended-release tablets. The drug will be launched in the doses of 750 mg, 1,125 mg and 1,500 mg. Strides Pharma already […]

Zydus Cadila receives US nod for generic version of Gilead Sciences’ Letairis

Pharmaceutical manufacturer Zydus Cadila said that it has received approval from the United States Food and Drug Administration for the sales of a generic equivalent of Gilead Sciences’ hypertension drug Letairis. Ambrisentan tablets had sales of $943 million in the US market in 2018, marking it among the bigger drugs in the market. Ambrisentan tablets […]

Lupin, Unichem, Alembic & Zydus okayed to sell generic Cialis in US

Indian pharmaceutical manufacturers Lupin, Unichem Laboratories and Alembic Pharmaceuticals said that they has received approval from the United States Food and Drug Administration to sell generic versions of Eli Lilly’s Cialis erectile dysfunction tablets, while rival Zydus Cadila said it has already begun selling the tablets on day 1. The patent for Cialis, owned by […]

Lupin gets nod to sell generic form of Viagra in the US

Pharmaceutical major Lupin said that it has received approval from the United States Food and Drug Administration for the sales of a generic equivalent of Pfizer Inc’s Viagra tablets. Sildenafil tablets is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. It is taken by mouth or via injection into a vein. Sildenafil […]

Zydus Cadila gets USFDA approval for schizophrenia drug

Pharmaceutical manufacturer Zydus Cadila said it received final approval from the United States Food and Drug Administration for sales of a generic version of Sunovion Pharmaceuticals’ Latuda tablets. Lurasidone tablets are used to treat certain conditions associated with bipolar disorder such as schizophrenia and depression. It also helps to decrease hallucinations. The drug will be […]

Caplin Point Labs gets USFDA nod for anticholinergic drug

Pharmaceutical manufacturer Caplin Point Laboratories Ltd said it received approval from the US Food and Drug Administration for sales of a generic equivalent of West-Ward Pharmaceuticals’ Robinul drug. Glycopyrrolate is a synthetic anticholinergic medication which works by blocking acetylcholine activity on smooth muscles and other tissues. Acetylcholine is a neurotransmitter, or a chemical that nerves […]

Glenmark Pharmaceuticals gets USFDA nod for sales of acne gel

Mumbai-based pharmaceutical firm Glenmark Pharmaceuticals said it received final approval from the US Food and Administration (USFDA) for the sale of a generic version of Valeant Bermuda’s acne treatment, BenzaClin. Clindamycin and benzoyl peroxide gel is a combination of clindamycin, an antibiotic and benzoyl peroxide, an antiseptic. The gel is mainly used on the skin […]

Lupin, Natco get FDA nod to launch generic version of Gleevec cancer drug

Pharmaceutical major Lupin and partner Natco Pharma received approval from the US Food and Drug Administration (FDA) to sell a generic equivalent of Novartis Pharmaceuticals’ Gleevec cancer tablets in the US market. Imatinib Mesylate Tablets, in 100 and 200 mg doses, have annual sales of around $655 million in the United States, Lupin said, making […]

Wockhardt gets nod to launch generic version of Novartis’ Gleevec cancer drug in USA

Indian pharmaceuticals manufacturer Wockhardt said it received approval from the United States Food & Drug Administration to launch a generic version of Novartis’ Leukemia drug Gleevec. The drug is estimated to have sales of $707 million in the US. The Indian company, which already has many of its products on US pharmacy shelves, said it […]

Lupin gets EU approval for own muscle disorder drug

Lupin said the European Commission (EC) has approved mexiletine for the symptomatic treatment of nondystrophic myotonic (NDM) disorders in adults. Non-dystrophic myotonic disorders are a group of rare, inherited neuromuscular disorders which cause the inability to relax muscles following voluntary contraction. Lupin’s NaMuscla reduces myotonia symptoms in adult patients, resulting in a significant improvement in […]