Generic Drug Roundup

Sun Pharma and SPARC have entered into a license agreement for commercialization of phenobarbital for injection in the United States. SPARC submitted a new drug application (NDA) to the FDA for this product for the treatment of neonatal seizures in February 2022. Currently, there are no phenobarbital injection products approved by the treat seizures in newborns.

Anil Raghavan

“SPARC’s benzyl alcohol and propylene glycol-free formulation of phenobarbital for injection is designed to minimize the risk of neonatal gasping syndrome, a life-threatening condition, which can be observed with the use of benzyl alcohol containing drug formulations,” Anil Raghavan, chief executive officer of SPARC, said in a press release.

SPARC’s phenobarbital sodium powder for injection is a benzyl alcohol and propylene glycol-free formulation. It was granted orphan drug designation by the FDA for of neonatal seizures. Currently marketed phenobarbital formulations are available under the DESI (Drug Efficacy Study Implementation) program. These are drugs approved between 1938 and 1962 for safety only. After 1962, all drugs must demonstrate safety and effectiveness. The FDA keeps up a list updated information on DESI-designated drugs here.

In other generic news:

Amneal Pharmaceuticals has received FDA approval for an abbreviated new drug application for leuprolide acetate for injection, which is indicated in the palliative treatment of advanced prostatic cancer. Leuprolide is the generic of AbbVie’s Lupron.

Ani Pharmaceuticals has received FDA approval for the abbreviated new drug application for trimethoprim tablets USP, 100 mg, which is used to treat urinary tract infections.

Camber Pharmaceuticals has released several new generics, including dabigatran etexilate capsules, which are a direct thrombin inhibitor indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. Camber’s capsules are available in 75 and 150 mg strengths in 60 count bottles. Camber has also launched a generic Genentech’s Esbriet (pirfenidone) tablets are indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Camber’s pirfenidone tablets are available in two strengths: 267 mg in 3-pack/90-count bottles (270 count total) and 801 mg strength in 90-count bottles.

Glenmark Pharmaceuticals has launched fingolimod capsules, 0.5 mg, the generic version of Novartis’ Gilenya, which is used to treat patients with relapsing multiple sclerosis.

Additionally, the FDA has approved Glenmark’s generic sodium phenylbutyrate tablets, the generic version of Horizon’s Buphenyl, which is used to help in the management of patients with urea cycle disorders (UCDs), a group of genetic disorders that prevent the body from detoxifying ammonia.

Lupin Pharmaceuticals has received tentative approval from the FDA for its abbreviated new drug application for doxycycline capsules, 40 mg, to a generic equivalent of Galderma’s Oracea to treat rosacea.