Glenmark Pharmaceuticals acquires and launches acetylcysteine injection

Glenmark acquired the ANDA for Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials from Aspen Pharma USA

Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution

Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure

Glenmark Pharmaceuticals USA launches Epinephrine Injection USP

This launch of Epinephrine Injection multiple-dose Vial is eligible for 180 days of CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act.

Zydus receives final approval from USFDA for Ibuprofen and Famotidine Tablets, 800 mg/26.6 mg

Ibuprofen and famotidine combination is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis

Senores Pharmaceuticals acquires ANDA for Roflumilast 250 mcg and 500 mcg tablets

Glenmark Pharmaceuticals USA launches Clindamycin Phosphate Foam, 1%

Glenmark’s Clindamycin Phosphate Foam, 1% is bioequivalent and therapeutically equivalent to Evoclin Foam, 1%, of Mylan Pharmaceuticals.

Lupin receives approval from USFDA for Ipratropium Bromide Nasal Solution

Ipratropium Bromide Nasal Solution is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis

Glenmark Pharmaceuticals USA launches Phytonadione Injectable Emulsion USP

According to IQVIATM sales data for the 12-month period ending November 2024, the Vitamin K1 Injectable Emulsion USP, 10 mg/mL market achieved annual sales of approximately $19.7 million

Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags

This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles

Alembic announces USFDA final approval for Brexpiprazole Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets