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 […]

Sun Pharma gets US FDA okay for eye drug

Sun Pharmaceutical Industries said it has got US Food and Drug Administration  approval for a new eye drug that will be used for lowering intraocular pressure or IOP  in patients with open-angle glaucoma or ocular hypertension. The medicine, latanoprost ophthalmic emulsion, was developed by group company Sun Pharma Advanced Research Co (SPARC), and was licensed by Sun Pharma, […]

Lupin gets USFDA nod for generic version of Valeant’s Xenazine

Pharma major Lupin said it received final approval for to launch a generic version of Valeant Pharmaceuticals’ Xenazine in the US. Tetrabenazine Tablets, 12.5 mg and 25 mg, has annual sales of approximately USD 288.1 million in the US, according to IQVIA. The tablet is indicated for the treatment of chorea, or involuntary movements associated […]

Zydus Cadila gets USFDA nod for NSAID Diclofenac Sodium

Pharmaceuticals maker Zydus Cadila said it received the final approval from the USFDA to market inflammation solution Diclofenac Sodium in the country. Diclofenac Sodium topical solution, 1.5%, is a non-steroidal anti-inflammatory drug (NSAID) used for symptomatic treatment of osteoarthritis of the knee. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad, the […]

Cipla, Strides Shasun launch HIV drug in the US after patent expires

Cipla and Strides Shasun, two Indian pharmaceutical companies, both said they have started shipping generic versions of Gilead Sciences’ HIV drug Viread after patent protection expired last week. Viread is among the bigger pharmaceutical drugs in the US and has sales of around $725 mln (Rs 4,650 cr) in the US every year. The patent […]