Indian pharmaceutical company Alembic Pharmaceuticals Limited has taken a significant step forward in the U.S. generic drug market. On July 1, 2024, the company announced it had received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Bosutinib tablets in 100 mg and 500 mg strengths. Bosutinib is a […]
Alembic Pharmaceuticals said it received tentative approval from the US Food & Drug Administration to launch a generic form of blood pressure tablet Opsumit. The tablet, including generic forms such as macitentan, is one of the bigger sellers in the market with estimated annual sales of $797 mn. Most of the generic drugs sold by […]
Sun Pharmaceutical Industries said it has received Emergency Use Authorization or EUA from India’s Drugs Controller General of India (DCGI) to manufacture and market a generic molnupiravir in India, a week after the US-FDA gave an EUA to its use in the US. The company has promised to make the oral drug, under the brand […]
Zydus Cadila said it received six-month exclusivity for the sale of generic tofacitinib, a drug that has annual sales of over $2 billion in the US. The exclusivity was provided by the US FDA, since Cadila Healthcare was the first to file an abbreviated new drug application or ANDA for the drug. An ANDA is […]
Indian pharmaceutical manufacturers Cipla and Glenmark Pharma said they received approval from the US Food and Drug Administration to launch a generic version of Sunovion Pharma’s inhaler therapy Brovana. The drug has substantial sales in the US of around $438 million in the 15 mcg dose and is approved for long-term, twice daily usage for […]
Alembic Pharmaceuticals said a new chemical developed by one of its joint ventures has become the first new chemical entity designed by Indian scientists to win approval from the US Food & Drug Administration. Umbralisib, created by its 50% JV Rhizen Pharma, is an anti-cancer drug that works by inhibiting phosphoinositide 3 kinase (PI3K) delta […]
Glenmark Pharmaceuticals said it received tentative approval from the United States Food & Drug Administration for a generic version of Mylan Pharma’s acne cream Evoclin. According to IQVIATM sales data, the EVOCLIN Foam 1% has sales of $17.0 million per year in the US. EVOCLIN Foam is indicated for topical application in the treatment of […]
Pharmaceutical manufacturer Alembic Pharmaceuticals Ltd said it received approval from the United States Food and Drug Administration (USFDA) for the sales of a therapeutic equivalent of Merck Sharp & Dohme Corp’s Sinemet Carbidopa/Levodopa sustained release tablets in the US market. Carbidopa and Levodopa Extended-Release tablets are used to treat symptoms of Parkinson’s disease and Parkinson’s-like […]
Pharmaceutical manufacturer Zydus Cadila said that it received final approval from the United States Food and Drug Administration (USFDA) for the sales of a generic equivalent of Nexium Delayed-Release capsules manufactured by Teva Pharmaceutical Industries. Esomeprazole, which belongs to a class of medicines called proton pump inhibitors, works by reducing the the amount of acid […]
Pharmaceutical major Lupin said it launched the asthma drug Budesonide Inhalation Suspension ampules in the US market. Budesonide Inhalation Suspension ampules are a generic equivalent of Pulmicort Respules Inhalation Suspension drugs of UK-based pharma firm AstraZeneca. Budesonide Inhalation Suspension ampules had annual sales of approximately USD 385.4 million in the US. Budesonide is used […]
Alembic Pharmaceuticals Ltd said it received final approval from the United States Food and Drug Administration for the sales of a therapeutic equivalent of Vesicare tablets manufactured by Astellas Pharma US, Inc. Solifenacin Succin tablets are used for the treatment of overactive bladders. Solifenacin pills improve the patient’s ability to control urination by relaxing the […]
Mumbai-based pharmaceutical firm Glenmark Pharmaceuticals said it received final approval from the United States Food and Drug Administration (USFDA) for sales of a generic equivalent of AstraZeneca Pharmaceuticals’ Nexium-Delayed Release capsules. Esomeprazole magnesium capsules are used to treat certain stomach and esophagus problems such as acid reflux and ulcers. It relieves symptoms such as heartburn, […]
Pharmaceutical manufacturer Zydus Cadila said it received the final approval for sales of a generic equivalent of Pfizer’s Thalitone tablets. Chlorthalidone tablets are used for the treatment of high blood pressure or hypertension. It is also used to treat fluid retention or edema in people with congestive heart failure, cirrhosis of the liver or kidney […]
Pharmaceutical major Lupin announced the launch of a generic equivalent of Lundbeck Pharms’ Onfi tablets in the US market. Clobazam is used to control seizures in adults and children 2 years of age and older who have Lennox-Gastaut syndrome. Lennox-Gastaut syndrome (LGS) or childhood epileptic encephalopathy is a pediatric epilepsy syndrome characterized by multiple seizure […]
Pharmaceutical major Lupin said that it received tentative approval from the United States Food and Drug Administration for the sales of a generic equivalent of Merck Sharp & Dohme Corp’s Emend Injection drug. Fosaprepitant, 150 mg had annual sales of $312 million in the US market. A tentative approval means that the company has to […]
Pharmaceutical company Unichem Laboratories said it received a tentative approval from the United States Food and Drug Administration (USFDA) to sell a generic equivalent of Johnson and Johnson Consumer Inc’s Zyrtec-D 12-hour Extended tablets. A tentative approval means that the company has to wait for all patent and other protections to expire before starting the […]
Hyderabad-headquartered Dr Reddy’s Laboratories said it has launched a therapeutic equivalent of AbbVie Inc’s AndroGel in the US market, a month after rival Lupin did so. Testosterone Gel is used for hormone replacement in men who are not able to produce enough testosterone. The medication is absorbed through the skin, enters the bloodstream, and helps […]
Pharmaceutical major Cipla and its subsidiary Cipla USA announced the phased launch of a generic therapeutic equivalent version of Sensipar, a branded drug manufactured by Amgen Inc. The launch, however, is a subject of ongoing litigation, Cipla said in a regulatory filing. Amgen’s Sensipar generated US sales of $1.43 billion in 2018. Cinacalcet hydrochloride tablets […]
Pharmaceutical manufacturer Zydus Cadila said it received approval from the United States Food and Drug Administration for the sales of a generic version of Valeant Pharmaceuticals’ Syprine capsules and a generic version of Actelion Pharmaceuticals’ Tracleer tablets. Trientine Hydrochloride capsules are chelating agents used for the treatment of Wilson’s disease, a genetic metabolic defect that […]
Pharmaceutical manufacturer Zydus Cadila said it received final approval from the United States Food and Drug Administration for sales of a generic version of Aventis Pharma’s Arava tablets. Leflunomide tablets, belonging to a class of medications called disease modifying anti-rheumatic drugs, is used of the treatment of rheumatoid arthritis. Zydus said that its tablets will […]
