Alembic Pharmaceuticals said it received tentative approval from the US Food & Drug Administration for launching a therapeutic equivalent of Latisse ophthalmic solution. Allergan Bimatoprost solution is used to treat loss of hair, or hypotrichosis, of the eyelashes. The solution, with an estimated US market size of $63 million, increases the length, thickness and darkness […]
A total of 1,104 people have died during clinical trials of various drugs and procedures in India in the last three years, according to the ministry of health and family welfare. However, not everyone who died during clinical trials are found to have died from the procedure through subsequent examinations. Only the patients who are […]
Sun Pharmaceutical Industries said it has launched the glucose regulating drug metformin hydrochloride in the United States. The tablets in two strengths — 500 mg and 1000 mg — have an addressable market size of around $443 million, the company said, quoting IQVIA. Metformin hydrochloride is sold in the US by Santarus Inc under the […]
Zydus Cadila said it received the final approval from the USFDA to sell Spironolactone Tablets, used to treat blood pressure and heart failure. The tablets, in strengths of 25 mg, 50 mg and 100 mg, will be used for lowering high blood pressure to prevent strokes, heart attacks and kidney problems. It is also used […]
Glenmark Pharmaceuticals said received approval from the United States Food & Drug Administration to sell cholesterol-lowering drug Colesevelam Hydrochloride in the country. The approval is for two packet sizes – 1.875 grams and 3.75 grams. Colesevelam Hydrochloride is the generic version of Daiichi Sankyo’s oral suspension Welchol. Welchol had annual sales of approximately $73.0 million for […]
Pharma major Lupin said its Goa facility has successfully completed an inspection by the UK Medicines and Healthcare Products Regulatory Authority. “There were no critical or major observations in the inspection,” it said, indicating that products made at the facility can continue to be sold in the UK market. This is not the first such […]
Cipla, one of India’s largest pharmaceuticals makers, said it has agreed to buy South African pharmaceuticals maker Mirren for 450 mln rand, or about Rs 225 cr. Mirren is a fast-growing OTC specialist with 152 mln rand of turnover in the last financial year, 123 mln in the preceding year and 83 mln in the […]
Zydus Cadila said it has received tentative regulatory approval from the US Food & Drug Administration for selling Deferasirox, used to chelate or expel excess iron from the blood. The drug is sold under names such as Exjade, Desirox, Defrijet, Desifer, Rasiroxpine and Jadenu. Tentative approval means that the company has to wait for all […]
Drug maker Cipla said it received final approval for selling a generic testosterone injection in the US. Cipla’s Testosterone Cypionate Injection 100mg /ml and 200mg /ml is an AO-rated generic equivalent version of Pharmacia and Upjohn’s Depo-Testosterone. Depo-Testosterone and its generic equivalents h ad US sales of approximately $191 M, according to IQVIA. The drug […]
Zydus Cadila, one of India’s largest drug makers, said it has received tentative approval to market tadalafil, the generic ingredient of the most popular erectile dysfunction drug Cialis, in the US market. The drug will be manufactured at the group’s facility at Moraiya, Ahmedabad. The USFDA approval comes weeks before Cialis is expected to lose patent […]
Indian Pharma major Lupin said it has signed an agreement with Japan-based generics maker Nichi-Iko to market its upcoming biosimilar drug, Etanercept, in the far eastern nation. Etanercept, already approved in the US, is used to treat inflammatory conditions. It is pending approval in Japan and Europe. According to Lupin, the non-US market for Etanercept […]
Alembic Pharmaceuticals said the USFDA has permitted it to sell antibiotic doxycycline in the US market. Doxycycline Hyclate Capsules USP, 50 mg and 100 mg, are considered a medium sized drug from a market perspective and had sales of US$ 80 million in 2017, according to IQVIA. It is sold by Pfizer under thebrand Vibramycin. […]
Suven Life Sciences said it has obtained one product patent each from China and the US related to its 5-HT4 and 5 HT6 compounds. These patents add to the similar protections won in countries such as India, Korea, Singapore, Canada, Japan and Australia in the past. The Chinese patent has the number CN105814020 and the American […]
Indian pharmaceutical giant Cipla Ltd said it would sell Eli Lilly and Co’s insulin glargine in India. Insulin glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. Unlike regular insulin shots — which have to be taken multiple times a day — basal insulin releases […]
India-based Sun Pharmaceutical Industries said it has launched an authorized generic version for Daiichi Sankyo’s cholesterol drug Welchol in the US market. The drug, whose compound name is colesevelam hydrochloride, had US sales of approximately US$ 520 million for the 12 months ending March 2018, as per IQVIA, the company said. The launch of the […]
Pharma player Suven Life Sciences said it received two patents from Australia and one from Singapore for new drugs that can be used for the treatment of disorders associated with Neurodegenerative diseases. “The granted patents include the class of selective H3 Inverse agonists and 5HT 6 compounds respectively and are being developed as therapeutic agents […]
Pharma player Strides Shasun said it has agreed in principle to merge its Australian business with the Australian operations of peer Apotex. Both have substantial businesses in Australia; Strides under the Arrow brand and Apotex under its primary brand. The merger will enable Strides, through the merged business, to become the leading player in the […]
Zydus Cadila, one of India’s largest pharmaceuticals manufacturers, said it got the the final approval from the US Food and Drug Administration to market Bumetanide, used to treat swelling. The drug is used for treating edema, or the swelling of legs, feet, hands or other parts due to the accumulation of excessive fluid in the […]
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 […]
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 […]
