Glenmark gets tentative US approval for Mylan’s acne cream

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 […]

Alembic Pharmaceuticals gets USFDA nod for Parkinson’s drug

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 […]

Zydus Cadila gets USFDA nod for stomach infection drug

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 […]

Lupin launches asthma drug in the US

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 gets USFDA nod for overactive bladder treatment drug

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 […]

Glenmark Pharmaceuticals gets USFDA nod for sales of stomach relief capsules

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, […]

Zydus Cadila gets USFDA approval for sales of hypertension drug

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 […]

Lupin launches generic epilepsy tablets in the US

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 […]

Unichem Laboratories receives tentative USFDA nod for sales of allergy drug

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 […]

Dr Reddy’s Laboratories launches Testosterone Gel in the US

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 […]

Cipla launches generic Sensipar amid legal battle with Amgen

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 […]

Zydus Cadila gets USFDA nod for generic Syprine, Tracleer drugs

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 […]

Zydus Cadila Gets USFDA Nod For Sales Of Rheumatoid Arthritis Drugs

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 […]

Glenmark receives nod from Russia for allergy spray

Mumbai-based pharmaceutical firm Glenmark Pharmaceuticals said it received approval from the Russian Health Ministry for the sales of Momate Rhino, also called Mometasone Furoate metered nasal spray, as an over-the-counter (OTC) drug. Over-the-counter drugs are medicines sold directly to a consumer without prescription from a healthcare professional, as opposed to prescription drugs, which may be […]

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 […]